BEUDAMED
    FDA Registration Active 🇦🇺 Australia

    da Vinci Xi Surgical System, Vision Cart

    Reg #: 3010885402 · FEI: 3010885402 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    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
    K131861

    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

    Proprietary Names

    da Vinci Xi Surgical System, Vision Cart da Vinci Xi Surgical System, Surgeon Console da Vinci Xi Surgical System, Patient Cart 8mm Permanent Monopolar Cautery Spatula, Xi 8mm Tenaculum Forceps, Xi 8mm Cannula Standard, Xi 8mm Snap-Fit Instrument, Xi 8mm Cardiac Probe Grasper, Xi 8mm Potts Scissors, Xi 8mm Medium Large Hem-O-Lok Clip Applier 8mm Resano Forceps, Xi 8mm Maryland Bipolar Forceps, Xi Instrument Release Kit, Xi 8mm Medium-Large Clip Applier, Xi 8mm Large Needle Driver, Xi 8mm Black Diamond Micro Forceps, Xi 8mm Flared Cannula, Xi 8mm Permanent Monopolar Cautery Hook, Xi 8mm Mega SutureCut Needle Driver, Xi 8mm Long Tip Forceps, Xi 8mm ProGrasp Forceps, Xi 8mm Blunt Obturator, Xi IRK,ENGLISH,IS4000 8mm Cannula Long, Xi 8mm Micro Bipolar Forceps, Xi Endoscope, 0 degrees, Xi 8mm Tip-Up Fenstrated Grasper, Xi 8mm Monopolar Curved Scissors, Xi 8mm Instrument Introducer, Xi 8mm Dual Blade Retractor, Xi 8mm Large Hem-O-Lok Clip Applier, Xi 8mm Small Grasping Retractor, Xi 8mm Small Clip Applier, Xi 8mm Fenstrated Bipolar Forceps, Xi 8mm Atrial Retractor Short Right, Xi Gage Pin, Xi Cleaning and Sterilization Kit 8mm Blunt Obturator Long, Xi Endoscope, 30 degrees, Xi 8mm Large Suturecut Needle Driver, Xi

    Establishment Types

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