Intuitive Surgical G.K.

FDA Device Registration & Listing · Tokyo, JP · Registration 3013283620

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013283620
FEI Number
3013283620
Entity Name
Intuitive Surgical G.K.
City/State/Country
Tokyo, JP
Establishment Address
3-9-2 Tatsumi, Koto-ku, Tokyo 135-0053, JP
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Intuitive Surgical, Inc. (Owner Number: 9028901)
Owner / Operator Contact Address
1266 Kifer Road, --, Sunnyvale, CA 94086, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Teleflex Obturators SureForm 45, SureForm 45 Reloads Endoscope Sterilization Tray Intuitive Surgical da Vinci Surgical System EndoWrist Stabilizer da Vinci S Surgical System Harmonic ACE EndoWrist One Suction/Irrigator, 8mm, da Vinci Si EndoWrist One Suction/Irrigator ICB, Instrument Control Box EndoWrist One Vessel Sealer , 8mm, da Vinci Si Endopass Delivery Instrument EndoPass Endoscopic Delivery Instruments Endoscope Sterilization Tray EndoWrist Vessel Sealer da Vinci Xi 12-8 mm Reducer Fluorescence Imaging Kit 8mm 0 degree endoscope 8mm 30 degree endoscope E-100 SynchroSeal da Vinci Xi 8 mm Hasson Cone da Vinci Xi 12 mm and Stapler Hasson Cone SureForm 60 Reloads SureForm 60 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 IS4000 ACCESSORY STARTER KIT IS4200 ACCESSORY STARTER KIT iESU SureForm 45 Curved Tip, SureForm 45 Gray Reload 5 mm Flared Cannula, da Vinci S, Si 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 IRIS System 1 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 IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps Introducer 5Fr , 5mm, da Vinci S, Si EndoWrist Introducer Instrument Endoscopic Instruments Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree da Vinci Surgi=cal System, S (HD) ILLUMINATOR,Y1865 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 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 STEREO ENDOSCOPE 12 mm Endoscope, 0° 12 mm Endoscope, 30° 8mm Monopolar Curved Scissors da Vinci SonicPro Cleaning System EndoWrist Suction Irrigator 12mm IS4000 Endoscopes and Accessories Alignment Target, 8.6mm Endoscope 8.5mm Endoscope, 30° Cannula, 8.5mm Endoscope 8.5mm Endoscope, 0° 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 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 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 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 Reprocessing Cover Catheter Guide Leak Test Adapter Controller Vision Probe Adapter and Suction Adapter Catheter Continuity Cable Ion™ Fully Articulating Catheter Flexision™ Biopsy Needle 23G Ion™ Peripheral Vision Probe PlanPoint™ Software Catheter Continuity Stand Flexision™ Biopsy Needle 21G Bath Probe Planning Laptop Swivel Connector System Cart Flexision™ Biopsy Needle 19G Ion Reprocessing Consumable Kit Intuitive Surgical EndoWrist Stabilizer 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 12 Mm & Stapler Bladeless Obturator Monopolar Cautery Cord Bipolar Cautery Cord 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 PROBE HOLDER SYSTEM 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 Fenestrated Bipolar Forceps, 5mm, da Vinci Si 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 Ion™ Peripheral Vision Probe Ion™ Fully Articulating Catheter Reprocessing Cover Endoscope Sterilization Tray Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Cadiere Forceps 8mm Round Tip Scissor Force Bipolar 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long 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° SP Cleaning and Sterilization Kit, da Vinci SP Endowrist Stapler Obturator Endowrist Stapler Cannula Endowrsit Stapler Reducer EndoWrist Stapler Cannula Kit EndoWrist Stapler Sheath 8mm Monopolar Curved Scissors Endoscopic Instruments EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci Tip Cover Accessory, da Vinci, da Vinci S, Si Tip Cover Accessory Ion Endoluminal System (IF1000) 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 EndoWrist Stapler 30 Instrument Curved Stapler 30 EndoWrist Stapler 30 Reloads EndoWrist Vessel Sealer Extend 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-04-23
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
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 2020-12-18
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
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 2011-08-31
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 2009-12-07
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 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 2016-11-17
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
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-12-09
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
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2008-03-28
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 2020-08-30
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2020-08-30
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 2012-12-17
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
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2019-02-27
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
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
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
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 2009-12-07
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
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 2022-02-07
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 2017-02-16
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2012-12-17
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 2009-12-07
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2009-12-07
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 2019-02-27
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
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
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2014-03-04
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
LKF Cannula, Manipulator/Injector, Uterine Obstetrics/Gynecology Class 2 884.4530 2007-11-26
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 2013-07-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-07-09
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
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-06-26
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 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 2015-05-20
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-05-20
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2018-08-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-11-02
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2009-12-07
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 2012-11-19
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 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 2011-11-04
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 2020-08-31
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
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 2010-09-20

Official Correspondent

Ted Claiborne

US Agent Details

Meghna Sridharan Email: Meghna.Sridharan@intusurg.com Phone: (408) 5232487

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
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13
K254228 Karl Storz SE & CO. KG KARL STORZ Trocars with Valve Seals 2026-05-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013283620. Last updated year: 2026. Please use registration number 3013283620 when referencing this establishment in official correspondence.
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