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

FDA Device Registration & Listing · Mexicali Baja California, MX · Registration 3016096100

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
3016096100
FEI Number
3016096100
Entity Name
Intuitive Surgical, S. de R.L. de C.V.
City/State/Country
Mexicali Baja California, MX
Establishment Address
Calzada Presidente Venustiano Carranza #1745, Colonia Calles, Mexicali Baja California 21226, MX
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

da Vinci SP® Surgical System, Model SP1098 da Vinci SP® Instruments and Accessories Ion™ Peripheral Vision Probe Ion™ Fully Articulating Catheter EndoWrist Stapler 45 System 8 mm SureForm 30 System SureForm 45 System SureForm 60 System EndoWrist Stapler 30 System EndoWrist Suction Irrigator 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° Universal Seal da Vinci Single-Site Instrument and Accessories 8 mm Bladeless Obturator (Optical) 8 mm Bladeless Obturator (Optical), Long 8mm Monopolar Curved Scissors E-100 SynchroSeal 8 mm Trocar, Long 5 mm to 8 mm Cannula Seal 8 mm Trocar, Standard Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree 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 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 IS4000 da Vinci EndoWrist Instruments 8mm Cobra Grasper 8mm Debakey Forceps 8mm Cadiere Forceps 8mm Round Tip Scissor 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 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 Force Bipolar 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 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 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 SP Access Port Kit, Large Incision (2.7 cm-7 cm) SP Access Port Kit, Small Incision (2.7 cm-4 cm) IS4000 Long Bipolar Forceps IS4000 Small Clip Applier IS4000 Long Bipolar Forceps Intuitive Surgical Vessel Sealer Extend 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 8mm SureForm Stapler 8mm SureForm Reloads 8mm SureForm 30 Curved-Tip Stapler 8mm Monopolar Curved Scissors Tip Cover Accessory, da Vinci, da Vinci S, Si Tip Cover Accessory da Vinci Xi 12-8 mm Reducer 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

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 2020-02-27
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 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 2017-02-16
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 2009-12-07
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2026-03-04
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
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 2018-04-24
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 2014-03-10
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
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 2009-12-07
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
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 2014-04-03
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 2020-08-31
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 2024-11-21
NAY System, Surgical, Computer Controlled Instrument Gastroenterology, Urology Class 2 876.1500 2021-01-08
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 2020-08-21
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 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 2022-02-07
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 2016-11-17
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2020-07-30

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
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
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

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-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.

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 3016096100. Last updated year: 2026. Please use registration number 3016096100 when referencing this establishment in official correspondence.
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