BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Intuitive Surgical Optics GmbH

    Reg #: 3017119401 · FEI: 3017119401 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    Intuitive Surgical Optics GmbH
    Registration Number
    3017119401
    FEI Number
    3017119401
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Dammweg 1
    City
    Emmendingen Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K191736

    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
    Laparoscope, General & Plastic Surgery GCJ
    Insufflator, Laparoscopic HIF

    Proprietary Names

    Da Vinci X/Xi 8mm Endoscope Plus, 30 degrees Da Vinci X/Xi 8mm Endoscope Plus, 0 degree 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