BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR

    K Number: K013718 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    61

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    Basic Information

    Device Name
    GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
    K Number
    K013718
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gynecare, A Div. of Ethicon, Inc.
    Date Received
    November 8, 2001
    Decision Date
    January 8, 2002
    Product Code
    OTO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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    Other Clearances by Gynecare, A Div. of Ethicon, Inc.

    K Number Device Name
    K040302 VERSAPOINT RESECTOSCOPIC SYSTEM