BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    12mm IS4000 Endoscopes and Accessories

    Reg #: 3013283620 · FEI: 3013283620 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Intuitive Surgical G.K.
    Registration Number
    3013283620
    FEI Number
    3013283620
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3-9-2 Tatsumi, Koto-ku
    City
    Tokyo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K142683

    Owner / Operator

    Firm Name
    Intuitive Surgical, Inc.
    Operator Number
    9028901
    Address
    1266 Kifer Road, --
    City
    Sunnyvale
    State
    CA
    Postal Code
    94086
    Country
    US
    Correspondent
    Mario Lowe

    Products

    Device Name Product Code
    System, Surgical, Computer Controlled Instrument NAY
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    12mm IS4000 Endoscopes and Accessories

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device