BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    da Vinci Xi 12 mm and Stapler Hasson Cone

    Reg #: 3010885402 · FEI: 3010885402 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Device Technologies Australia
    Registration Number
    3010885402
    FEI Number
    3010885402
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    158 Hollinsworth Road
    City
    Marsden Park New South Wales
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K153126

    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
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    da Vinci Xi 12 mm and Stapler Hasson Cone da Vinci Xi 8 mm Hasson Cone

    Establishment Types

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