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
System, Surgical, Computer Controlled Instrument NAY
Staple, Implantable GDW
Stapler, Surgical GAG
Electrosurgical, Cutting & Coagulation & Accessories GEI
Insufflator, Laparoscopic HIF

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