Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018126215

FEI Number

3018126215

Entity Name

Intuitive Surgical, Inc.

City/State/Country

Sunnyvale, CA, US

Establishment Address

1050 Kifer Road, Sunnyvale, CA 94086, US

Establishment Type(s)

Manufacture Medical Device

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

K220023

PMA Number

N/A

All Registered Proprietary Names

Intuitive Surgical Vessel Sealer Extend EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System Universal Seal 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 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 E200 Generator Da Vinci SP Vision Cart Force Bipolar IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps 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 SP Access Port Kit, Large Incision (2.7 cm-7 cm) SP Access Port Kit, Small Incision (2.7 cm-4 cm) IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Cadiere Forceps 8mm Round Tip Scissor 8mm Monopolar Curved Scissors

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	2020-08-21
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	2026-03-04
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	2025-01-15
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
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	2015-04-30
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2015-04-30
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	2025-06-16
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	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	2022-02-07

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
K131563	Opus Ksd, Inc.	SUBQ IT! BIOABSORBABLE SKIN CLOSURE SYSTEM	2014-04-09
K131705	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RADIAL RELOAD WITH TRI-STAPLE TECHNOLOGY	2013-07-01
K103263	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY	2010-11-22
K130717	Covidien, Formerly US Surgical A Divison of Tyco H	ENDO GIA RELOAD	2013-04-18
K221006	Covidien	GIA Stapler with Tri-Staple Technology	2022-04-29

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0005-2021	N/A	2	Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm, Item Code 030454 - 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 3018126215. Last updated year: 2026. Please use registration number 3018126215 when referencing this establishment in official correspondence.