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

    GYNECARE TVT EXACT CONTINENCE SYSTEM

    K Number: K132054 · Decision Aug 23, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    172
    Review Days
    51

    Basic Information

    Device Name
    GYNECARE TVT EXACT CONTINENCE SYSTEM
    K Number
    K132054
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ETHICON, INC.
    Date Received
    July 3, 2013
    Decision Date
    August 23, 2013
    Product Code
    OTN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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