Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015612252

FEI Number

3015612252

Entity Name

INTUITIVE SURGICAL, INC.

City/State/Country

Santa Clara, CA, US

Establishment Address

3410 Central Expressway, --, Santa Clara, CA 95051, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Intuitive Surgical, Inc. (Owner Number: 9028901)

Owner / Operator Contact Address

1266 Kifer Road, --, Sunnyvale, CA 94086, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 da Vinci Xi Surgical System (IS4000) da Vinci X Surgical System (IS4200) da Vinci Single-Site Accessories 8 mm Harmonic ACE Curved Shears EndoWrist Vessel Sealer da Vinci Single-Site Instruments Endoscopic Instruments EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci SureForm 45 Curved Tip, SureForm 45 Gray Reload EndoWristStapler 30 and Stapler 30Reloads EndoWristStapler 45 and Stapler 45 Reloads Da Vinci Monopolar and Bipolar Adapters EndoWrist Stapler 45 Reload, Blue EndoWrist Stapler Motor Pack EndoWrist Stapler 45 Reload, Green EndoWrist Stapler 45 EndoWrist Stapler Cannula Seal EndoWrist Stapler Release Kit EndoWrist Stapler Sheath EndoWrist Stapler Cable Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System EndoWrist 5mm Thoracic Grasper 8 mm Assist Cannula 12 mm Assist Cannula CIM pivot arm CIM extended height adjustable arm CIM height adjustable arm CIM extended pivot arm Roll stands and charts da Vinci SP Surgical System EndoWrist Vessel Sealer da Vinci X Surgical System (IS4200) da Vinci Xi Surgical System (IS4000) 8mm Large Needle Driver 8mm Long Bipolar Grasper 8mm Cadiere Forceps 8mm Cobra Graspers 8mm Maryland Bipolar Forceps 8mm Curved Bipolar Dissector 8mm Mega SutureCut Needle Driver 8mm Long Tip Forceps 8mm Micro Bipolar Forceps 8mm Large SutureCut Needle Driver 8mm ProGrasp Forceps 8mm Force Bipolar 8mm Fenestrated Bipolar Forceps da Vinci X Surgical System Ion Endoluminal System (IF1000) da Vinci Force Feedback ProGrasp Forceps da Vinci Force Feedback Large Needle Driver da Vinci Force Feedback Cadiere Forceps da Vinci Force Feedback Mega SutureCut Needle Driver da Vinci Force Feedback Maryland Bipolar Forceps da Vinci Force Feedback Fenestrated Bipolar Forceps Cannula Seal, 8mm Energy Activation Cable, CONMED, da Vinci Si CABLE,PMED,COVIDIEN FORCE TRIAD Accessory Base Starter Kit Energy Activation Cable, ERBE, da Vinci Si Energy Activation Cable, Gyrus, da Vinci Si Energy Activation Cable, Ethicon, da Vinci Si Energy Activation Adapter, Ethicon GEN11, da Vinci Si VIO-ICB Mounting Bracket Option, Connect, da Vinci Si da Vinci Surgical System, Si KIT,CABLE,FIBER OPTIC,ST,CIRCULAR-MT M-F Camera Starter Kit 12 mm Endoscope, 0° ASSY,VSS VISION SYSTEM W/AVP,VS3000 CABLE KIT,BLUE FIBERCONNECT,20M ASSY,PSCART,IS3000,4-ARM 3DHD Camera Head and Cable ASSY,SSC,IS3000 VisionBoom¿ Extension Cable Energy Activation Cable, Valleylab, da Vinci Si ASSY,PSCART,IS3000,3-ARM 12 mm Endoscope, 30° Endoscope Sterilization Tray INTUITIVE SURGICAL STEREO ENDOSCOPE 12 mm Endoscope, 0° 12 mm Endoscope, 30° da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 MARS 1 Streme App da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 Universal Seal (5-12 mm) NIR Handheld Camera Tray da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 Ion Peripheral Vision Probe Ion Fully Articulating Catheter Reprocessing Cover da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 EndoWrist Stapler 30 Instrument Curved Stapler 30 EndoWrist Stapler 30 Reloads DEVICE,ENERGY,ERBE VIO 300D Green System Cable, da Vinci Si 12 mm Endoscope Cannula Mount, COV, da Vinci 8 mm Cannula with Outlet, da Vinci S, Si Power Cord, 3.7 Meter, 115V, US, C13 > Hospital Grade Bipolar Energy Activation Cable, Gyrus ACMI, da Vinci, da Vinci S Blue System Cable, da Vinci Si Camera Starter Kit, PAL Wide Angle, Type 2 5 mm Sharp Obturator, da Vinci S, Si Tenaculum Forceps , 8mm, da Vinci S, Si Medium-Large Clip Applier , 8mm, da Vinci S, Si Accessory Base Starter Kit PreCise Bipolar Forceps , 8mm, da Vinci S, Si Camera Starter Kit, Panasonic HD Endowrist Permanent Cautery Instrum Light Guide Cable Adapter Cannula Holder, Twist¿Lock, da Vinci 8 mm Cannula with Outlet, Long, da Vinci S, Si Camera Head Video Cable, Panasonic® HD Camera Head Sterile Adapter Resano Forceps , 8mm, da Vinci S, Si 8 mm Blunt Obturator, da Vinci S, Si Curved Scissors , 5mm, da Vinci S, Si Valve Hook , 8mm, da Vinci S, Si Snap-fit Blue Blade, da Vinci, da Vinci S, Si Large SutureCut Needle Driver , 8mm, da Vinci S, Si Camera Arm Sterile Adapter 8 mm to 5 mm Cannula Reducer, da Vinci Long Tip Forceps , 8mm, da Vinci S, Si Permanent Cautery Hook , 8mm, da Vinci S, Si EndoWrist Permanent Cautery Instruments Red System Cable, da Vinci® S¿, da Vinci S 8 mm Instrument Cannula, Long, da Vinci S, Si Maryland Dissector , 5mm, da Vinci S, Si Round Tip Scissors , 5mm, da Vinci S, Si Cautery Spatula Tip, 5mm, da Vinci, da Vinci S, Si Black Diamond Micro Forceps , 8mm, da Vinci S, Si Dual Blade Retractor , 8mm, da Vinci S, Si Needle Driver , 5mm, da Vinci S, Si Schertel Grasper , 5mm, da Vinci S, Si Atrial Retractor Short Right , 8mm, da Vinci S, Si Potts Scissors , 8mm, da Vinci S, Si Bipolar Energy Activation Cable, CONMED, da Vinci, da Vinci S 12 mm Endoscope Cannula Mount, APPMED, da Vinci S, Si Assembly, VSC, VS2000 Panasonic HD, Domestic 8 mm Instrument Cannula, da Vinci S, Si Monopolar Cautery , 5mm, da Vinci S, Si Small Clip Applier , 8mm, da Vinci S, Si Monopolar Energy Activation Cable, ERBE EndoWrist Stapler Cannula Blunt Obturator, da Vinci S, Si Assembly, Patient Side Cart EndoWrist Stapler Cannula Reducer, da Vinci S, Si Assembly, Vision System Assembly, Surgeon Side Console Bipolar Energy Activation Cable, CONMED EndoWrist Stapler Cannula, da Vinci S, Si Bipolar Energy Activation Cable, ERBE Energy Activation Cable, Ethicon Bipolar Energy Activation Cable, Gyrus ACMI Bipolar Energy Activation Cable, Valleylab da Vinci Surgical System, S Endowrist Bipolar Instruments Endowrist Instruments Endoscopic Instruments 3D Camera, Wide Angle, NTSC Cleaning and Sterilization Kit, English 12 mm Endoscope Cannula Mount, Balloon Port Camera Head Video Cable, Ikegami® HD 3DHD Camera Head and Cable (Panasonic HD) Camera Head Video Cable, Sumitomo® SD Fiber Cable Cleaning Kit Monopolar Energy Activation Cable, CONMED, da Vinci, da Vinci S 3D Camera, Wide Angle, PAL da Vinci® 8 mm Cannula Gage Pin, da Vinci, da Vinci S, Si Permanent Cautery Spatula , 8mm, da Vinci S, Si Assembly, PSCart, IS2000, 4-Arm, G1.1 Light Guide Cable Adapter, da Vinci, da Vinci S 8 mm Sharp Obturator, Long, da Vinci S, Si Micro Bipolar Forceps, 8mm, da Vinci S, Si Fenestrated Bipolar Forceps , 8mm, da Vinci S, Si Small Grasping Retractor , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, COV Illuminator Lamp Module, Model Y1866 8 mm Cannula Seal, da Vinci, da Vinci S, Si 8 mm Sharp Obturator, da Vinci S, Si DeBakey Forceps , 5mm, da Vinci S, Si Cobra Grasper , 8mm, da Vinci S, Si Grasping Retractor , 8mm, da Vinci S, Si Large Clip Applier , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, ETH, da Vinci 8 mm to 5 mm Cannula Reducer, da Vinci S, Si Monopolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S 5 mm Blunt Obturator, da Vinci S, Si Thoracic Grasper , 8mm, da Vinci S, Si Thoracic Grasper , 5mm, da Vinci S, Si Snap-fit Paddle Blade, da Vinci, da Vinci S, Si Assembly, Vision System w/TS, NTSC, VS2000 HD, Domestic Assembly, Cannula Mount, Dual Jaw COV, ECM, da Vinci S, Si Bipolar Energy Activation Cable, ERBE, da Vinci, da Vinci S 12 mm Endoscope Cannula Mount, ETH/TAUT, da Vinci S, Si Bifurcated Light Guide Assembly, Surgeon Side System, IS2000 Cautery Hook Tip, 5 mm, da Vinci, da Vinci S, Si Round Tip Scissors , 8mm, da Vinci S, Si Cadiere Forceps , 8mm, da Vinci S, Si Curved Bipolar Dissector , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci S, Si Large Needle Driver , 8mm, da Vinci S, Si Camera Starter Kit, NTSC Wide Angle, Type 2 Monopolar Energy Activation Cable, ERBE, da Vinci, da Vinci S DeBakey Forceps , 8mm, da Vinci S, Si Maryland Bipolar Forceps , 8mm, da Vinci S, Si 12 mm Endoscope Cannula Mount, Balloon Port, da Vinci Cannula 5 mm Regular, da Vinci S, Si 8 mm Blunt Obturator, Long, da Vinci S, Si Snap-Fit Scalpel Instrument , 8mm, da Vinci S, Si Mega Needle Driver , 8mm, da Vinci S, Si Mega SutureCut Needle Driver , 8mm, da Vinci S, Si 12 mm Instrument Cannula, da Vinci S, Si Prograsp Forceps , 8mm, da Vinci S, Si Bowel Grasper , 5mm, da Vinci S, Si Bipolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S Double Fenestrated Grasper , 8mm, da Vinci S, Si Camera Starter Kit, PAL High Mag, Type 2 12 mm Blunt Obturator, da Vinci S, Si Curved Scissors , 8mm, da Vinci S, Si Monopolar Energy Activation Cable, Megadyne, da Vinci, da Vinci S Accessory Base Starter Kit, Multi-Specialty, ETH 3DHD Camera Head and Cable (Ikegami HD) Bipolar Energy Activation Cable, Valleylab, da Vinci, da Vinci S CAMERA STARTER KIT,PANASONIC,HD STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2 IS4200 ACCESSORY STARTER KIT STARTER KIT,IS3000,HD ENDOSCOPE,12MM IS4000 ACCESSORY STARTER KIT da Vinci Xi da Vinci X da Vinci SP Surgical System da Vinci SP Surgical System, Vision Cart da Vinci SP Surgical System, Patient Cart da Vinci SP Surgical System, Surgeon Console Intuitive Surgical da Vinci Surgical System EndoWrist Stabilizer da Vinci S Surgical System Da Vinci E-200 Generator da Vinci E-200 Electrosurgical Generator MP Instrument Reprocessing Connector, 2 Device MP Instrument Reprocessing Connector, 1 Device Ion Peripheral Vision Probe Ion Fully Articulating Catheter IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000 Endoscope Sterilization Tray Force Bipolar Da Vinci E200 Generator Da Vinci SP Vision Cart Endoscope Sterilization Tray da Vinci Xi Surgical System with Table Motion Endopass Delivery Instrument EndoPass Endoscopic Delivery Instruments Intuitive Surgical da Vinci S Surgical System, Model IS2000 with Connect OnSite and Wireless Connectivity Option da Vinci Xi da Vinci X da Vinci Force Feedback Mega SutureCut Needle Driver da Vinci Force Feedback ProGrasp Forceps SP Cleaning and Sterilization Kit, da Vinci SP Intuitive Surgical EndoWrist Stabilizer Harmonic Ace Curved Shears , 8mm, da Vinci S, Si Harmonic ACE® Curved Shears Insert, da Vinci, da Vinci S, Si Harmonic Ace Curved Shears , 5mm, da Vinci Harmonic Ace Curved Shears , 5mm, da Vinci S, Si 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000) Harmonic Ace Curved Shears da Vinci Xi 12-8 mm Reducer 12 Mm & Stapler Bladeless Obturator ASSY,VSS VISION SYSTEM W/AVP,VS3000 ASSY,PSCART,IS3000,4-ARM ASSY,PSCART,IS3000,3-ARM ASSY,SSC,IS3000 Medium-Large Clip Applier, da Vinci SP da Vinci SP Surgical System, Vision Cart Instrument Arm Drape, da Vinci SP EnergyShield Monopolar Cautery Cord, da Vinci SP Cautery Spatula Tip, da Vinci SP Bipolar Cautery Cord, da Vinci SP Cautery Hook Tip, da Vinci SP da Vinci SP Surgical System, Surgeon Console da Vinci SP Surgical System EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Cleaning and Sterilization Kit, da Vinci SP Monopolar Cautery Instrument, da Vinci SP Maryland Bipolar Forceps, da Vinci SP Cadiere Forceps, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP MCS Tip, da Vinci SP da Vinci SP Surgical System, Patient Cart Needle Driver, da Vinci SP Camera Sheath, da Vinci SP Monopolar Curved Scissors, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP Round Tooth Retractor, da Vinci SP Instrument Sheath, da Vinci SP da Vinci SP Surgical System, Vision Cart Cannula, Circular, 25 mm x 100 mm, da Vinci SP Needle Driver, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Cleaning and Sterilization Kit, da Vinci SP Medium-Large Clip Applier, da Vinci SP da Vinci SP Surgical System, Patient Cart Camera Sheath, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP Instrument Arm Drape, da Vinci SP Cadiere Forceps, da Vinci SP Cautery Spatula Tip, da Vinci SP Bipolar Cautery Cord, da Vinci SP da Vinci SP Surgical System MCS Tip, da Vinci SP EnergyShield Monopolar Cautery Cord, da Vinci SP EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP SP Access Port Kit, Small Incision (2.7 cm-4 cm) SP Access Port Kit, Large Incision (2.7 cm-7 cm) Round Tooth Retractor, da Vinci SP Monopolar Curved Scissors, da Vinci SP da Vinci SP Surgical System, Surgeon Console Instrument Sheath, da Vinci SP Maryland Bipolar Forceps, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP Monopolar Cautery Instrument, da Vinci SP Cautery Hook Tip, da Vinci SP 8mm Monopolar Curved Scissors Valve Hook , 8mm, da Vinci IS Endoscopic Instruments Curved Scissors , 5mm, da Vinci Blade Protector, Snap-fit, da Vinci, da Vinci S, Si Monopolar Cautery , 5mm, da Vinci Mega SutureCut Needle Driver , 8mm, da Vinci IS Endoscopic Control System Bowel Grasper , 5mm, da Vinci Snap-Fit Scalpel Instrument , 8mm, da Vinci da Vinci SP Firefly Imaging System Endoscope Sterilization Tray EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System Da Vinci Force Feedback Cadiere Forceps Da Vinci Force Feedback Mega SutureCut Needle Driver Da Vinci Force Feedback Maryland Bipolar Forceps Da Vinci Force Feedback Fenestrated Bipolar Forceps Da Vinci Force Feedback Large Needle Driver Da Vinci Force Feedback ProGrasp Forceps EndoWrist Suction Irrigator NIR Handheld Camera Light Source NIR Handheld Camera NIR Handheld Camera Control Unit (CCU) NIR Handheld Camera Tray Harmonic ACE Curved Shears Insert, da Vinci, da Vinci S, Si Harmonic Ace Curved Shears , 5mm, da Vinci S, Si 5 MM HARMONIC ACE (USED WITH DA VINCI IS1200/2000/3000) Harmonic Ace Curved Shears , 5mm, da Vinci Harmonic Ace Curved Shears Harmonic Ace Curved Shears , 8mm, da Vinci S, Si NIR Handheld Camera System Starter Kit Da Vinci 5 Tower - Model: T5000 Da Vinci 5 Robot - Model: R5000 Da Vinci 5 Console - Model: C5000 Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree Intuitive Surgical Vessel Sealer Extend Harmonic Curved Shears, 5mm, da Vinci Harmonic Curved Shears, 8mm, da Vinci Harmonic Curved Shears Instrument Harmonic Curved Shears Harmonic Curved Shears, 8mm, da Vinci S, Si Harmonic Curved Shears Insert, da Vinci, da Vinci S, Si Harmonic Curved Shears, 5mm, da Vinci S, Si da Vinci SP Surgical System (SP1098) VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000 da Vinci Single-Site Instrument and Accessories NIR Handheld Camera Tray SRK,OUS,IS4000 IS4000 ACCESSORY STARTER KIT IS4200 ACCESSORY STARTER KIT NIR Handheld Camera Light Guide Automated Reprocessing Connector Set, 8mm Endoscope, Xi SP Reprocessing Connector, 2 devices SP Instrument Reprocessing Tray MP Instrument Reprocessing Tray SP Reprocessing Connector, 1 device SP Endoscope Reprocessing Tray AUTOMATED REPROCESSING CONNECTOR SET,8MM ENDOSCOPE,IS4000 Cleaning and Disinfection Tray, Catheter and Vision Probe, IF1000 da Vinci Instrument Reprocessing Tray Universal Seal (5-12mm) Fenestrated Bipolar Forceps, 5mm, da Vinci Si IS Endowrist Bipolar Instrument Micro Bipolar Forceps , 8mm, da Vinci PreCise Bipolar Forceps , 8mm, da Vinci da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 Dual Blade Retractor , 8mm, da Vinci Atrial Retractor , 8mm, da Vinci EndoWrist Endoscopic Instruments Round Tip Scissors , 5mm, da Vinci DeBakey Forceps , 5mm, da Vinci Maryland Dissector , 5mm, da Vinci Schertel Grasper , 5mm, da Vinci Pericardial Dissector , 8mm, da Vinci Thoracic Grasper , 8mm, da Vinci Needle Driver , 5mm, da Vinci Resano Forceps , 8mm, da Vinci Fine Tissue Forceps , 8mm, da Vinci da Vinci Xi da Vinci X Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 30° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 0° Universal Seal (5-12 mm) Handheld Camera Light Guide Adapter Handheld Camera Light Guide Da Vinci Handheld Camera Handheld Camera Sterilization Tray ICB, Instrument Control Box EndoWrist One Vessel Sealer, 8mm, da Vinci Si da Vinci SonicPro Cleaning System EndoWrist Accessories, da Vinci Xi EndoWrist Instruments, da Vinci Xi IRISeg Introducer 5Fr , 5mm, da Vinci S, Si EndoWrist Introducer Instrument Endoscopic Instruments da Vinci Xi da Vinci X PK® Instrument Cord, G400 Generator, da Vinci, da Vinci S, Si EndoWrist PK Dissecting Forceps PK Dissecting Forceps PK Dissecting Forceps , 8mm, da Vinci S, Si PK® Instrument Cord, PK/SP Generator, da Vinci, da Vinci S, Si IRK,OUS,IS4000 IRK,OUS,IS3000 IRK,OUS,W/O VS,IS3000 IRK,OUS,W/O VS,IS4000 PANASONIC CAMERA HEAD,HDTV,SCHOELLY da Vinci Xi Vision Probe Bag CAMERA ARM DRAPE,IS3000 INSTRUMENT ARM DRAPE IS2000 COLUMN DRAPE, IS4000 ARM 4 PROXIMAL DRAPE, IS4200 INSTRUMENT ARM DRAPE, IS4000 Instrument Arm Drape, da Vinci SP SP Monopolar Curved Scissors Extended Range SP Monopolar Cautery Instrument SP Medium Large Clip Applier SP Needle Driver Extended Range SP Force Bipolar SP Needle Driver SP Monopolar Curved Scissors SP Cadiere Forceps SP Force Bipolar and SP Instruments 1.5 (Extended Range and Enhanced Wrist Instruments) SP Maryland Bipolar Forceps SP Cadiere Forceps, Extended Range SP Round Tooth Retractor Extended Range SP Maryland Bipolar Forceps, Extended Range SP Fenestrated Bipolar Forceps SP Force Bipolar, Extended Range 8 mm SureForm 30 Stapler 8 mm SureForm 30 Reload, White 8 mm SureForm 30 Curved-Tip Stapler 8 mm SureForm 30 Reload, Blue 8 mm SureForm 30 Reload, Gray da Vinci Insufflator Tube Set with Smoke Evacuation 8mm Endoscope, 30°, Gen5 CABLE KIT,BLUE FIBERCONNECT,20M Stainless Steel Endoscope Reprocessing Tray, 8mm, Gen5 8mm Hex Cannula, Standard 8mm Hex Cannula, Long da Vinci 5 Force Feedback Fenestrated Bipolar Forceps Da Vinci 5 Tower - Model: T5000 Blue System Cable, Type B, 7m da Vinci 5 Force Feedback Maryland Bipolar Forceps UPGRADE,CO2 TANK INTERFACE,CGA940,US Double Receptacle System Cable Extension Kit da Vinci 5 Force Feedback Cadiere Forceps da Vinci 5 Force Feedback Large Needle Driver Da Vinci 5 Robot - Model: R5000 Single Receptacle System Cable Extension Kit da Vinci 5 Force Feedback Mega SutureCut Needle Driver da Vinci Insufflator da Vinci 5 Force Feedback ProGrasp Forceps Da Vinci 5 Console - Model: C5000 8mm Endoscope, 0°, Gen5 Endoscope Sterilization Tray da Vinci Surgical System (IS5000) ICB, Instrument Control Box EndoWrist One Vessel Sealer , 8mm, da Vinci Si da Vinci Xi da Vinci X Da Vinci E-200 Electrosurgical Generator CAMERA HEAD,HDTV,TOSHIBA HD,FIREFLY100 12 mm Endoscope, 0° ASSY,CABLE,DOCO TO ILLUMINATOR 8.5 mm Endoscope, 0° DOUBLE CAMERA CONTROLLER (DOCO),TOSHIBA HD,GLENAIR 12 mm Endoscope, 30° da Vinci Fluorescence Imaging Vision System DUCT,RIGHT,ILLUMINATOR,FIREFLY100 ASSY,CABLE,CORE TO DOCO STARTER KIT,FF100 VISION Camera Head Cable Fluorescence Imaging Illuminator Fluorescence Imaging Camera Head and Cable Kit DUCT,LEFT,ILLUMINATOR,FIREFLY100 8.5 mm Endoscope, 30° BRACKET(SET),DOCO/ILLUMINATOR RESTRAINING,IS3000 Stapler-8mm Cannula Reducer EndoWrist® Stapler 45 Stapler Cannula Blunt Obturator Stapler 45 Reload, White Stapler 45 Reload, Green Stapler Cannula, Long Stapler Cannula Blunt Obturator, Long Stapler 45 Reload, Blue Stapler Cannula Stapler Release Kit Stapler Sheath 10-12mm+Stapler Cannula Seal EndoWrist® Stapler 45 Curved-Tip EndoWrist Stapler System Starter Kit - 45 mm SRK,ENGLISH,IS4000 EndoWrist Stapler Cannula Kit EndoWrist Stapler System Starter Kit without Cannula Kit 45 mm Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP MCS Tip, da Vinci SP Round Tooth Retractor, da Vinci SP Instrument Sheath, da Vinci SP EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Camera Sheath, da Vinci SP SP Cleaning and Sterilization Kit, da Vinci SP da Vinci SP Surgical System, Patient Cart Needle Driver, da Vinci SP Cautery Spatula Tip, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP da Vinci SP Surgical System, Vision Cart Cadiere Forceps, da Vinci SP da Vinci SP Surgical System, Surgeon Console Monopolar Curved Scissors, da Vinci SP Cautery Hook Tip, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP EnergyShield Monopolar Cautery Cord, da Vinci SP da Vinci SP Surgical System Monopolar Cautery Instrument, da Vinci SP Bipolar Cautery Cord, da Vinci SP Maryland Bipolar Forceps, da Vinci SP Medium-Large Clip Applier, da Vinci SP Blue System Cable, Type A to Type B, 7m Harmonic ACE da Vinci SP Firefly Imaging System Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories da Vinci Surgi=cal System, S (HD) ILLUMINATOR,Y1865 da Vinci Xi Monopolar Curved Scissors , 8mm, da Vinci S, Si IS Endoscopic Instruments IS da Vinci Surgical System Tip Cover Accessory, da Vinci, da Vinci S, Si Monopolar Curved Scissors , 8mm, da Vinci Instrument/Accessory Steriliz Tray Single Instrument Tray, da Vinci, da Vinci S, Si Instrument Tray, da Vinci, da Vinci S, Si Procedure Tray, da Vinci, da Vinci S, Si da Vinci Surgical System (IS5000) Universal Seal Ion Fully Articulating Catheter Reprocessing Cover Ion Peripheral Vision Probe Ion reprocessing accessory kit Tip Cover Accessory, da Vinci, da Vinci S, Si Tip Cover Accessory da Vinci Si da Vinci X da Vinci Xi 8mm Monopolar Curved Scissors da Vinci SP SureForm 45 Curved-Tip Stapler da Vinci SP SureForm 45 Stapler da Vinci Xi da Vinci X 8.5-13 mm Cannula Seal Fluorescence Imaging Kit 8mm 0 degree endoscope 8mm 30 degree endoscope Xi X Monopolar Curved Scissors, 8mm, da Vinci S, Si Ion Endoluminal System, Model IF1000 Single-Site 10 mm Accessory Cannula, da Vinci Si Single-Site Port for 8.5 mm Endoscope, da Vinci Si Single-Site¿ 5 x 300 mm Flexible Blunt Obturator, da Vinci Si Single-Site Bipolar Maryland, 5mm, da Vinci Si da Vinci Single-Site Port da Vinci Single-Site Instruments and Accessories Single-Site 10 mm Blunt Obturator, da Vinci Si Single-Site Starter Kit US, Cholecystectomy, 20 Cases Single-Site 5 x 250 mm Flexible Blunt Obturator, da Vinci Si Single-Site Maryland Dissector , 5mm, da Vinci Si Single-Site Monopolar Cautery , 5mm, da Vinci Si Single-Site Fundus Grasper , 5mm, da Vinci Si 5 mm Flared Cannula, da Vinci S, Si NIR Handheld Camera Tray da Vinci SP® Surgical System, Model SP1098 da Vinci SP® Instruments and Accessories IRISeg IS4200 ACCESSORY STARTER KIT STARTER KIT,IS3000,HD ENDOSCOPE,12MM CAMERA STARTER KIT,PANASONIC,HD IS4000 ACCESSORY STARTER KIT CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2 STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) Ion Fully Articulating Catheter da Vinci Fluorescence Imaging Vision System da Vinci Firefly Imaging System EndoWrist One Suction/Irrigator, 8mm, da Vinci Si EndoWrist One Suction/Irrigator da Vinci SP Surgical System IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps Ion Endoluminal System (IF1000) Cleaning and Sterilization Kit, da Vinci SP Cannula, Circular, 25 mm x 100 mm, da Vinci SP Monopolar Cautery Instrument, da Vinci SP da Vinci SP Surgical System, Patient Cart Bipolar Cautery Cord, da Vinci SP da Vinci SP Surgical System, Surgeon Console Round Tooth Retractor, da Vinci SP Obturator, Circular, 25 mm x 100 mm, da Vinci SP MCS Tip, da Vinci SP Cautery Spatula Tip, da Vinci SP Instrument Sheath, da Vinci SP da Vinci SP Surgical System EnergyShield Monopolar Cautery Cord, da Vinci SP EndoWrist SP Camera, 0 degree, da Vinci SP Medium-Large Clip Applier, da Vinci SP Camera Sheath, da Vinci SP da Vinci SP Surgical System, Vision Cart Needle Driver, da Vinci SP EntryGuide Kit C.6.6.6, 25 mm x 100 mm, da Vinci SP Maryland Bipolar Forceps, da Vinci SP Monopolar Curved Scissors, da Vinci SP Fenestrated Bipolar Forceps, da Vinci SP Cadiere Forceps, da Vinci SP Instrument Arm Drape, da Vinci SP Cautery Hook Tip, da Vinci SP IS3000 Stapler 45 Instrument IS4000 EndoWrist Stapler 30 IS3000 Stapler 45 Accessories IS4000 Stapler 45 Accessories IS4000 Stapler 45 Instrument da Vinci Xi surgical drapes

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-07-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-10
GEH	Unit, Cryosurgical, Accessories	General, Plastic Surgery	Class 2	878.4350	2009-12-10
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-07-23
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-07-23
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-09-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2017-09-22
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2023-08-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-05-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2025-07-09
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2024-03-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-09-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2014-06-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-06-18
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-10-27
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-10-27
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-06-01
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2022-06-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2026-03-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	1998-01-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-25
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-08-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-03-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-09
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2020-06-26
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-05-01
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2016-03-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-03-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-02-16
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-11-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-12-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-19
NVE	Washer, Cleaner, Automated, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2024-11-27
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-09-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-30
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-08-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-08-13
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2026-01-23
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2026-01-23
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-08-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-01-20
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-05-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-06-16
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-10
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-08-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2010-09-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-11-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2014-12-12
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2014-12-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-01-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-07-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-02-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2007-11-26
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2025-09-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-09-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2016-01-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-08-15
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-08-15
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-01-15
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-02-16
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
OWN	Confocal Optical Imaging	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-03-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-31
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-07-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2017-08-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-08-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-12-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2021-04-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-03-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-03-09
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-03-14
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-03-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
EQH	Source, Carrier, Fiberoptic Light	Ear, Nose, Throat	Class 1	874.4350	2024-03-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-06-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-08-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2013-07-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-07-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2026-02-04
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-02-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2009-12-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2012-12-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-01-14
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-18
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-30
NVE	Washer, Cleaner, Automated, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-10-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-08-21
GCI	Laryngoscope, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2020-08-21
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-12-11
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-12-11
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2010-09-20
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-12-28
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2020-07-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-11-21
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-12-29
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-12-29
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2024-03-15
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-03-15
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2019-06-13
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2026-01-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2012-02-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-04-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-04-07
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2011-04-07
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2014-07-28
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2014-07-28
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-07-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-07-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2015-04-13
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2015-04-13
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-12-02
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-12-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-05-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-07
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2008-03-28
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-07-25
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-03-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2019-12-03
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-11-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-04-24
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-04-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-04-08
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2025-04-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-12-29
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2020-11-05
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-11-05
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-04-01
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-09-03
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-12-21
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2011-12-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-12-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2012-12-17
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2024-03-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-02-27
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-12-31
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-12-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-02-16
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-04-15
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-05-19
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-05-19
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2021-05-19
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-08-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-04-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2015-04-30
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-09-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-03
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
ERY	Drape, Surgical, Ent	General, Plastic Surgery	Class 2	878.4370	2017-06-02

Official Correspondent

Ted Claiborne

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Intuitive Surgical, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
3038188839	Intuitive Surgical Bulgaria EOOD	Parvomay Plovdiv, BG
2955842	INTUITIVE SURGICAL, INC.	SUNNYVALE, CA, US
3017119401	Intuitive Surgical Optics GmbH	Emmendingen Baden-Wurttemberg, DE
3042953929	Intuitive Solutions	Carrollton, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2021	N/A	2	Endo GIA Auto Suture Gray Universal Articulating Loading Unit 30 mm - 2.0 mm, Item Code 030450 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0002-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 2.5 mm, Item Code 030451 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0003-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 30 mm - 3.5 mm, Item Code 030452 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Z-0004-2021	N/A	2	Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.

Similar Registrations

Registration Number	Establishment Name	Location
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3013283620	Intuitive Surgical G.K.	Tokyo, JP
3007593944	Asensus Surgical, Inc.	Morrisville, NC, US
8043903	SCHOELLY FIBEROPTIC, GMBH	DENZLINGEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015612252. Last updated year: 2026. Please use registration number 3015612252 when referencing this establishment in official correspondence.