BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Intuitive Surgical, Inc.

    Reg #: 3015241782 · FEI: 3015241782 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    51
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    Intuitive Surgical, Inc.
    Registration Number
    3015241782
    FEI Number
    3015241782
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4550 W Watkins Street, Suite 120
    City
    Phoenix
    State
    AZ
    ZIP
    85043
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232610

    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
    Insufflator, Laparoscopic HIF
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ
    Laparoscopy Kit FDE
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    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 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 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° IS4200 ACCESSORY STARTER KIT STARTER KIT,IS3000,HD ENDOSCOPE,12MM CAMERA STARTER KIT,PANASONIC,HD IS4000 ACCESSORY STARTER KIT CAMERA STARTER KIT,PAL WIDE ANGLE,TYPE 2 STARTER KIT,IS3000,FF100 ENDOSCOPE,8.5MM AND 12MM STARTER KIT,IS3000,HD ENDOSCOPE,8.5MM NIR Handheld Camera System Starter Kit

    Establishment Types

    Manufacture Medical Device