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510(k) Data Aggregation

    K Number
    K101440
    Device Name
    GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012
    Manufacturer
    GENERIC MEDICAL DEVICES, INC.
    Date Cleared
    2010-06-18

    (25 days)

    Product Code
    OTN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERIC MEDICAL DEVICES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMD Universal Urinary Incontinence Sling™-1012 is indicated for use in women as a suburethral sling for the treatment of Stress Urinary Incontinence (SUI) resulting from either urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The GMD Universal Urinary Incontinence Sling™-1012 is a sterile, single use device for the treatment of female Stress Urinary Incontinence. The Universal Urinary Incontinence Sling™ 1012 is comprised of a polypropylene knitted mesh protected by a disposable polypropylene sheath with a surgical suture loop at each end for attachment of the sling to GMD's reusable T-slot trocars (sold separately). The surgical suture loop is used for inside-out / bottom-up and outside-in / top-down approaches. The method of placement and surgical approach chosen by the physician should be appropriate for the patient's diagnosis and anatomy.
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