BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Intuitive Surgical Optics GmbH

    Reg #: 3038187466 · FEI: 3038187466 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

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    Registration Details

    Registration Name
    Intuitive Surgical Optics GmbH
    Registration Number
    3038187466
    FEI Number
    3038187466
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Guerickestrasse 1
    City
    Freiburg 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

    US Agent

    Business Name
    INTUITIVE SURGICAL, INC.
    Contact Name
    Mario Lowe
    Address
    1266 Kifer Rd
    City
    Sunnyvale
    State
    CA
    ZIP
    94086
    Country
    US
    Email
    [email protected]
    Phone
    408 5232100

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

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

    Establishment Types

    Manufacture Medical Device