FDA Registration
Active
🇲🇽 Mexico
Intuitive Surgical, S. de R.L. de C.V.
Reg #: 3016096100
·
FEI: 3016096100
·
Expires 2026
Products
8
Proprietary Names
342
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- Intuitive Surgical, S. de R.L. de C.V.
- Registration Number
- 3016096100
- FEI Number
- 3016096100
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Calzada Presidente Venustiano Carranza #1745, Colonia Calles
- City
- Mexicali Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K182371
Owner / Operator
- Firm Name
- Intuitive Surgical, Inc.
- Operator Number
- 9028901
- Address
- 1266 Kifer Road, --
- City
- Sunnyvale
- State
- CA
- Postal Code
- 94086
- Country
- US
- Correspondent
- Ted Claiborne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Surgical, Computer Controlled Instrument | NAY | Class 2 | Gastroenterology, Urology | No | 2020-02-27 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2021-09-09 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2023-08-15 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2023-08-15 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2026-03-04 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-11-25 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2020-07-30 |
| Instrument, Ultrasonic Surgical | LFL | Class U | Unknown | No | 2015-04-13 |
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
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
Flexision Biopsy Needle 23G
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
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
Harmonic ACE
Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)
8mm Large Needle Driver
8mm Long Bipolar Grasper
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 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
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device