BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    8mm Fenestrated Bipolar Forceps

    Reg #: 3010157088 · FEI: 3010157088 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    13
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Device Technologies Australia
    Registration Number
    3010157088
    FEI Number
    3010157088
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    30 Graystone Street
    City
    Tingalpa Queensland
    Country
    AU

    Regulatory Submissions

    510(k) Number
    K214095

    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
    System, Surgical, Computer Controlled Instrument NAY
    Laparoscope, General & Plastic Surgery GCJ

    Proprietary Names

    8mm Fenestrated Bipolar Forceps 8mm Force Bipolar 8mm ProGrasp Forceps 8mm Maryland Bipolar Forceps 8mm Mega SutureCut Needle Driver 8mm Cobra Graspers 8mm Large Needle Driver 8mm Curved Bipolar Dissector 8mm Micro Bipolar Forceps 8mm Long Tip Forceps 8mm Cadiere Forceps 8mm Large SutureCut Needle Driver 8mm Long Bipolar Grasper

    Establishment Types

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