FDA Registration
Active
🇺🇸 United States
Intuitive Surgical, Inc.
Reg #: 3018126215
·
FEI: 3018126215
·
Expires 2026
Products
7
Proprietary Names
112
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Intuitive Surgical, Inc.
- Registration Number
- 3018126215
- FEI Number
- 3018126215
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1050 Kifer Road
- City
- Sunnyvale
- State
- CA
- ZIP
- 94086
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183107
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 | 2020-08-21 |
| 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 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-03-15 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-01-23 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2021-12-02 |
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 Round Tip Scissor
8mm Monopolar Curved Scissors
da Vinci Force Feedback Mega SutureCut Needle Driver
da Vinci Force Feedback ProGrasp Forceps
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
SureForm 45, SureForm 45 Reloads
da Vinci SP Firefly Imaging System
8mm SureForm Stapler
8mm SureForm Reloads
8mm SureForm 30 Curved-Tip Stapler
Da Vinci E-200 Generator
da Vinci E-200 Electrosurgical Generator
da Vinci Force Feedback Large Needle Driver
da Vinci Force Feedback Cadiere Forceps
da Vinci Force Feedback Maryland Bipolar Forceps
da Vinci Force Feedback Fenestrated Bipolar Forceps
Establishment Types
Manufacture Medical Device