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
System, Surgical, Computer Controlled Instrument NAY
Staple, Implantable GDW
Stapler, Surgical GAG
Laparoscope, General & Plastic Surgery GCJ
Insufflator, Laparoscopic HIF
Electrosurgical, Cutting & Coagulation & Accessories GEI
System, X-Ray, Angiographic IZI

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