Intuitive Surgical, Inc.

FDA Device Registration & Listing · Peachtree Corners, GA, US · Registration 3022626486

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
3022626486
FEI Number
3022626486
Entity Name
Intuitive Surgical, Inc.
City/State/Country
Peachtree Corners, GA, US
Establishment Address
3795 Data Dr, Peachtree Corners, GA 30092, US
Establishment Type(s)
Repack or Relabel Medical 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

Fenestrated Bipolar Forceps, 5mm, da Vinci Si da Vinci Single-Site Instrument and Accessories da Vinci Xi 12-8 mm Reducer 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 EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System da Vinci Xi 8 mm Hasson Cone da Vinci Xi 12 mm and Stapler Hasson Cone 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 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 8 mm Trocar, Long 5 mm to 8 mm Cannula Seal 8 mm Trocar, Standard 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 EndoWrist 5mm Thoracic Grasper ICB, Instrument Control Box EndoWrist One Vessel Sealer, 8mm, da Vinci Si E-100 SynchroSeal Handheld Camera Light Guide Adapter Handheld Camera Light Guide Da Vinci Handheld Camera Handheld Camera Sterilization Tray 8mm Monopolar Curved Scissors 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 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° 8mm Monopolar Curved Scissors Endowrist Stapler Obturator Endowrist Stapler Cannula Endowrsit Stapler Reducer EndoWrist Stapler Cannula Kit EndoWrist Stapler Sheath Endoscopic Instruments EndoWrist Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci S, Si Cardiac Probe Grasper Cardiac Probe Grasper , 8mm, da Vinci 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 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 EndoWrist Vessel Sealer 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 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 Tip Cover Accessory, da Vinci, da Vinci S, Si Tip Cover Accessory da Vinci X Surgical System (IS4200) da Vinci Xi Surgical System (IS4000) Da Vinci Xi 8mm Endoscope, 0 degree, Da Vinci Xi 8mm Endoscope, 30 degree IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps Force Bipolar da Vinci SP Firefly Imaging System Monopolar Cautery Cord Bipolar Cautery Cord EndoWrist Vessel Sealer Extend 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 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 da Vinci SP® Surgical System, Model SP1098 da Vinci SP® Instruments and Accessories Universal Seal Harmonic ACE Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long Da Vinci Handheld Camera Handheld Camera Light Guide Handheld Camera Light Guide Adapter

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 2013-07-09
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2013-07-09
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
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2016-11-17
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
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
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 2020-08-31
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
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2014-03-10
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 2018-05-31
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2020-08-30
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 2019-07-18
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2018-04-24
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2021-06-22
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 2022-02-07
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 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
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 2010-09-21
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 2024-11-21
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 2011-11-04
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 2017-08-31
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2017-08-31
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 2018-08-13
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
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 2018-05-01
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2014-04-03
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 2020-02-27
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-03-04
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 2019-07-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2019-07-31
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2015-11-02
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2024-09-03

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
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.

Similar Registrations

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3013942591 INTUITIVE SURGICAL, INC. Sunnyvale, CA, US
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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 3022626486. Last updated year: 2026. Please use registration number 3022626486 when referencing this establishment in official correspondence.
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