BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Laparoscope Lens Shield Device

    K Number: K160172 · Decision Apr 21, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    5
    Review Days
    85

    Basic Information

    Device Name
    Laparoscope Lens Shield Device
    K Number
    K160172
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medeon Biodesign, Inc
    Date Received
    January 27, 2016
    Decision Date
    April 21, 2016
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GCJ), ordered by most recent decision date.

    Disposable Trocars

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    8 mm Assist Cannula; 12 mm Assist Cannula

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Boehringer Laboratories Liver Retractor

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medical Monitor (32HS710S)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Arthrex Synergy Vision Endoscopic Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LAGIS Suction Irrigation System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Medeon Biodesign, Inc

    K Number Device Name
    K192891 Laparoscope Lens Shield Device (LENS)
    K170103 Laparoscope Lens Shield Device (LENS)
    K160117 AbClose - Port Site Closure Device
    K151117 Laparoscope Lens Shield Device