Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007084728

FEI Number

3007084728

Entity Name

Intuitive Surgical, S. de R.L. de C.V.

City/State/Country

Mexicali Baja California, MX

Establishment Address

Circuito Internacional Sur #21-A, Parque Industrial Nelson, Carretera a San Luis R.C., Km 14, Mexicali Baja California 21397, MX

Establishment Type(s)

Manufacture Medical Device,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

Expiration Date (Year)

2026

510(k) Number

K152663

PMA Number

N/A

All Registered Proprietary Names

EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000) Ion Fully Articulating Catheter Ion Peripheral Vision Probe Ion Fully Articulating Catheter da Vinci Xi 12-8 mm Reducer 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAY	System, Surgical, Computer Controlled Instrument	Gastroenterology, Urology	Class 2	876.1500	2023-08-15
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
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2024-04-15
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	2016-11-17
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-02

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
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 3007084728. Last updated year: 2026. Please use registration number 3007084728 when referencing this establishment in official correspondence.