BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    SureForm 45, SureForm 45 Reloads

    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
    K183224

    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
    Staple, Implantable GDW

    Proprietary Names

    SureForm 45, SureForm 45 Reloads

    Establishment Types

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