BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Endoscopic Trocar

    K Number: K180208 · Decision Apr 9, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    75

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    Basic Information

    Device Name
    Disposable Endoscopic Trocar
    K Number
    K180208
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fengh Medical Co., Ltd.
    Date Received
    January 24, 2018
    Decision Date
    April 9, 2018
    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

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    Other Clearances by Fengh Medical Co., Ltd.

    K Number Device Name
    K242679 Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)
    K202467 Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
    K182476 Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads