Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001675293

FEI Number

3001675293

Entity Name

INTUITIVE SURGICAL, INC.

City/State/Country

Sunnyvale, CA, US

Establishment Address

1266 Kifer Road, Sunnyvale, CA 94086, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

K252069

PMA Number

N/A

All Registered Proprietary Names

3D Model Viewer Video Review (also referred to as Replay) 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 MP Instrument Reprocessing Connector, 2 Device MP Instrument Reprocessing Connector, 1 Device Ion Endoluminal System (IF1000) da Vinci Xi da Vinci X da Vinci X Surgical System (IS4200) da Vinci Xi Surgical System (IS4000) 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 ICB, Instrument Control Box EndoWrist One Vessel Sealer , 8mm, da Vinci Si Ion Endoluminal System, Model IF1000 SP Access Port Kit, Large Incision (2.7 cm-7 cm) SP Access Port Kit, Small Incision (2.7 cm-4 cm) Endowrist Stapler Obturator Endowrist Stapler Cannula Endowrsit Stapler Reducer EndoWrist Stapler Cannula Kit EndoWrist Stapler Sheath da Vinci Xi SP Cleaning and Sterilization Kit, da Vinci SP 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 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 da Vinci SP Firefly Imaging System da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 da Vinci Xi 8 mm Hasson Cone da Vinci Xi 12 mm and Stapler Hasson Cone da Vinci Xi SureForm 60 Reloads SureForm 60 8mm Monopolar Curved Scissors DEVICE,ENERGY,ERBE VIO 300D da Vinci Xi Surgical System (IS4000) da Vinci X Surgical System (IS4200) 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 Force Feedback Mega SutureCut Needle Driver da Vinci Force Feedback ProGrasp Forceps 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 Single-Site Instrument and Accessories Ion Endoluminal System, Model IF1000 EndoWrist Suction Irrigator 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 Ion Peripheral Vision Probe Ion Fully Articulating Catheter 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 da Vinci® Xi and X Surgical Systems, Model IS4000 and Model IS4200 da Vinci E-200 Electrosurgical Generator da Vinci Xi da Vinci X MARS 1 Streme App 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 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long IS4000 ACCESSORY STARTER KIT IS4200 ACCESSORY STARTER KIT da Vinci Xi 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 IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000 da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 da Vinci Xi da Vinci X Universal Seal (5-12 mm) da Vinci Xi 12-8 mm Reducer da Vinci Xi da Vinci X Fluorescence Imaging Kit 8mm 0 degree endoscope 8mm 30 degree endoscope da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 Da Vinci E-200 Generator da Vinci E-200 Electrosurgical Generator ICB, Instrument Control Box EndoWrist One Vessel Sealer, 8mm, da Vinci Si 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 da Vinci Xi Surgical System (IS4000) da Vinci X Surgical System (IS4200) da Vinci SP Surgical System (SP1098) 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 EndoWrist One Suction/Irrigator, 8mm, da Vinci Si EndoWrist One Suction/Irrigator Endoscope Sterilization Tray 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 SureForm 45, SureForm 45 Reloads Intuitive Surgical da Vinci Surgical System EndoWrist Stabilizer da Vinci S Surgical System Ion Peripheral Vision Probe Ion Fully Articulating Catheter Reprocessing Cover da Vinci SP Advanced Access Port Kit EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 Introducer 5Fr , 5mm, da Vinci S, Si EndoWrist Introducer Instrument Endoscopic Instruments E-100 SynchroSeal VIO DV 2,INTEGRATED ELECTRO SURGICAL UNIT IESU,INTEGRATED ELECTRO SURGICAL UNIT,IS4000 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 da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 EndoWrist 5mm Thoracic Grasper da Vinci Xi 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 8mm SureForm Stapler 8mm SureForm Reloads 8mm SureForm 30 Curved-Tip Stapler EndoWrist Vessel Sealer Extend EndoWrist Accessories, da Vinci Xi EndoWrist Instruments, 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 da Vinci SP® Surgical System, Model SP1098 da Vinci SP® Instruments and Accessories 8mm Monopolar Curved Scissors Harmonic ACE Curved Shears, 5mm, da Vinci S/Si EndoWrist resuable Accessories, da Vinci S/Si EndoWrist Instruments, da Vinci S/Si Harmonic ACE Curved Shears, 8mm, da Vinci S/Si PROBE HOLDER SYSTEM IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps da Vinci Firefly Imaging System da Vinci Fluorescence Imaging Vision System INTUITIVE SURGICAL STEREO ENDOSCOPE 12 mm Endoscope, 0° 12 mm Endoscope, 30° NIR Handheld Camera System Starter Kit da Vinci Single-Site Accessories 8 mm Harmonic ACE Curved Shears EndoWrist Vessel Sealer da Vinci Single-Site Instruments da Vinci Xi da Vinci X da Vinci SP® Instruments and Accessories da Vinci SP® Surgical System, Model SP1098 Intuitive Surgical EndoWrist Stabilizer Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree Endoscope Sterilization Tray Endoscope Sterilization Tray 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 Ion Endoluminal System (IF1000) IS Endowrist Bipolar Instrument Micro Bipolar Forceps , 8mm, da Vinci PreCise Bipolar Forceps , 8mm, da Vinci 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 Monopolar Cautery Cord Bipolar Cautery Cord SP Endoscope, 0° Da Vinci E-200 Electrosurgical Generator da Vinci Si da Vinci X da Vinci Xi Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree IS3000 Stapler 45 Instrument IS4000 EndoWrist Stapler 30 IS3000 Stapler 45 Accessories IS4000 Stapler 45 Accessories IS4000 Stapler 45 Instrument Da Vinci E200 Generator Da Vinci SP Vision Cart da Vinci Xi SP Cleaning and Sterilization Kit, da Vinci SP EndoWrist Instruments, da Vinci Xi EndoWrist Instruments, da Vinci S/Si Intuitive Surgical® da Vinci® Fluorescence Imaging Vision System da Vinci Xi Surgical System, Patient Cart da Vinci Xi Surgical System, Vision Cart da Vinci Xi Surgical System, Surgeon Console 8mm Micro Bipolar Forceps, Xi Endoscope, 0 degrees, Xi 8mm Monopolar Curved Scissors, Xi 8mm Large Needle Driver, Xi 8mm Fenstrated Bipolar Forceps, Xi 8mm Cardiac Probe Grasper, Xi 8mm Potts Scissors, Xi 8mm Mega SutureCut Needle Driver, Xi 8mm Long Tip Forceps, Xi 8mm Medium Large Hem-O-Lok Clip Applier 8mm Resano Forceps, Xi 8mm Tip-Up Fenstrated Grasper, Xi 8mm Atrial Retractor Short Right, Xi 8mm Small Clip Applier, Xi Gage Pin, Xi 8mm Large Suturecut Needle Driver, Xi 8mm Blunt Obturator, Xi 8mm Instrument Introducer, Xi 8mm Dual Blade Retractor, Xi 8mm Maryland Bipolar Forceps, Xi 8mm Large Hem-O-Lok Clip Applier, Xi Endoscope, 30 degrees, Xi 8mm Blunt Obturator Long, Xi 8mm Small Grasping Retractor, Xi IRK,ENGLISH,IS4000 8mm Cannula Long, Xi 8mm Black Diamond Micro Forceps, Xi 8mm Flared Cannula, Xi 8mm ProGrasp Forceps, Xi 8mm Cannula Standard, Xi 8mm Snap-Fit Instrument, Xi Instrument Release Kit, Xi 8mm Medium-Large Clip Applier, Xi 8mm Permanent Monopolar Cautery Hook, Xi 8mm Permanent Monopolar Cautery Spatula, Xi 8mm Tenaculum Forceps, Xi Cleaning and Sterilization Kit Endoscope Sterilization Tray 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 Tip Cover Accessory, da Vinci, da Vinci S, Si Tip Cover Accessory 5 mm Flared Cannula, da Vinci S, Si 8.5-13 mm Cannula Seal da Vinci SP SureForm 45 Curved-Tip Stapler da Vinci SP SureForm 45 Stapler 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 Universal Seal (5-12 mm) da Vinci SP Surgical System ASSY,VSS VISION SYSTEM W/AVP,VS3000 ASSY,PSCART,IS3000,4-ARM ASSY,PSCART,IS3000,3-ARM ASSY,SSC,IS3000 SureForm 45 Curved Tip, SureForm 45 Gray Reload Da Vinci Handheld Camera Handheld Camera Light Guide Handheld Camera Light Guide Adapter Teleflex Obturators da Vinci Fluorescence Imaging Vision System da Vinci Firefly Imaging System IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Cadiere Forceps 8mm Round Tip Scissor Universal Seal (5-12mm) 12mm IS4000 Endoscopes and Accessories da Vinci SP Surgical System 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 da Vinci SonicPro Cleaning System Handheld Camera Light Guide Adapter Handheld Camera Light Guide Da Vinci Handheld Camera Handheld Camera Sterilization Tray Da Vinci 5 Robot - Model: R5000 Da Vinci 5 Tower - Model: T5000 Da Vinci 5 Console - Model: C5000 Intuitive Surgical da Vinci®,da Vinci S®, and da Vinci Si® Surgical Systems and EndoWrist Instruments and Accessories Endoscopic Instruments EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci da Vinci Xi Surgical System with Table Motion Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) Ion Fully Articulating Catheter da Vinci Xi da Vinci X da Vinci SP Surgical System (SP1098) da Vinci Xi da Vinci Surgical System (IS5000) Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 30° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 0° 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 5 Tower - Model: T5000 Da Vinci 5 Robot - Model: R5000 Da Vinci 5 Console - Model: C5000 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 EndoWristStapler 30 and Stapler 30Reloads EndoWristStapler 45 and Stapler 45 Reloads da Vinci SP® Surgical System, Model SP1098 da Vinci SP® Instruments and Accessories

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	2025-07-31
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2010-09-21
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	2022-06-17
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	2024-07-11
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	2012-02-08
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-10-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-01-08
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2012-11-19
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
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	2009-12-07
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-01-15
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
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-09
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-12-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2018-07-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-07-06
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-02-07
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	2025-07-02
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	2024-07-10
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-01-12
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
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-12-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2017-02-16
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-11-17
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2021-09-09
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	2023-08-09
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-11-08
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	2020-06-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-02
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-03-14
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
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	2025-12-22
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	2023-08-03
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	2020-11-02
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	2025-05-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-08-19
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-02-16
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-04-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-12-22
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
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2011-08-31
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-08-14
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
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-02-22
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-22
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-12-18
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	2025-04-08
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	2026-02-04
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	2019-11-25
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2019-11-25
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
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	2024-07-19
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-05-31
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	2022-02-16
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-10-17
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-17
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2024-10-17
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2018-05-01
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
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	2020-02-27
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	2020-08-21
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	Class 2	884.4530	2007-11-26
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
IZI	System, X-Ray, Angiographic	Radiology	Class 2	892.1600	2022-03-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2022-03-02
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2022-03-02
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	1998-01-06
FDE	Laparoscopy Kit	Gastroenterology, Urology	Class 2	876.1500	2024-03-14
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	2021-01-12
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2026-02-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2009-12-10
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
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-08-21
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2019-06-13
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-06-22
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-09-24
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	2024-11-21
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-03-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-05-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-10-31
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	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	2020-08-21
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
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2020-02-26
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-11-02
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-08-21
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2021-02-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-02-26
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	2014-04-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2020-08-21
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	2011-11-04
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2012-12-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2021-12-29
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	2007-11-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-01-14
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2024-07-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-08-17
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
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-09-03
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-04-23
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	2015-05-20
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-05-20
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	2015-01-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-01-14
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	2009-12-07
NVE	Washer, Cleaner, Automated, Endoscope	Gastroenterology, Urology	Class 2	876.1500	2008-10-02
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	2025-09-09
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	2009-12-10
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
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2016-01-20
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-04-15
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	2024-07-09
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2020-10-29
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	2012-12-17
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	2025-07-21
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	2023-08-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-08-15
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2025-12-15

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
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
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.

Similar Registrations

Registration Number	Establishment Name	Location
3013942591	INTUITIVE SURGICAL, INC.	Sunnyvale, CA, US
3009941480	LISI MEDICAL REmmele	Big Lake, MN, US
3015612252	INTUITIVE SURGICAL, INC.	Santa Clara, CA, US
3013283620	Intuitive Surgical G.K.	Tokyo, JP
3007593944	Asensus Surgical, Inc.	Morrisville, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001675293. Last updated year: 2026. Please use registration number 3001675293 when referencing this establishment in official correspondence.