FDA Registration
Active
🇺🇸 United States
INTUITIVE SURGICAL, INC.
Reg #: 2955842
·
FEI: 3008615487
·
Expires 2026
Products
5
Proprietary Names
42
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- INTUITIVE SURGICAL, INC.
- Registration Number
- 2955842
- FEI Number
- 3008615487
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 950 Kifer Road
- City
- SUNNYVALE
- State
- CA
- ZIP
- 94086
- Country
- US
Regulatory Submissions
- 510(k) Number
- K241814
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 | 2024-11-21 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2025-04-08 |
| Stapler, Surgical | GAG | Class 2 | General Hospital | No | 2025-04-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2026-01-23 |
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2024-03-15 |
Proprietary Names
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
da Vinci SP SureForm 45 Curved-Tip Stapler
da Vinci SP SureForm 45 Stapler
da Vinci SP Advanced Access Port Kit
Da Vinci E200 Generator
Da Vinci SP Vision Cart
SP Endoscope, 0°
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
Establishment Types
Manufacture Medical Device