BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    SynchroSeal

    Reg #: 3016607092 · FEI: 3016607092 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Device Technologies Australia
    Registration Number
    3016607092
    FEI Number
    3016607092
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Ground Floor, 6-8 Compark Circuit
    City
    Mulgrave Victoria
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K191280

    Owner / Operator

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

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    System, Surgical, Computer Controlled Instrument NAY

    Proprietary Names

    SynchroSeal E-100

    Establishment Types

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