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510(k) Data Aggregation

    K Number
    K983164
    Device Name
    RESTORE (AKA RE/STOR)
    Manufacturer
    NEBL, INC.
    Date Cleared
    1999-03-05

    (176 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEBL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Restore device is indicated for the prevention or decrease of episodes of urine leakage in women with stress incontinence.
    Device Description
    Restore Female Continence device is a simple, noninvasive suction cup which fits over the urinary meatus. Air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via suction. If inadequate suction occurs. Aquaphor or a petroleum based ointment can be applied to the outside rim of the device to enhance suction. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and, therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intraabdominal and intravesical pressure during valsalva, thereby decreasing or preventing leakage.
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    K Number
    K971359
    Device Name
    RESTORE (A.K.A. CAPSURE)
    Manufacturer
    NEBL, INC.
    Date Cleared
    1997-11-14

    (217 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEBL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Restore Continence Device is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence. Although it can help control urinary incontinence, it will not correct the underlying cause of the condition.
    Device Description
    The Restore Female Continence device is a simple, non invasive suction cup device which fits over the urinary meatus. Similar to a suction cup, air is squeezed out of the device's cap while it is positioned over the urinary meatus. When the cap is released, the device self-adheres to the anterior vaginal wall over the meatus via self-suction. If inadequate suction occurs, Aquaphor or an equivalent ointment can be applied to the outside rim of the device to enhance adhesion. The suction or negative pressure created by the device causes coaptation and occlusion of the meatus and therefore, increased urethral resistance. The amount of negative pressure generated by the device is optimized to counteract increases in intra-abdominal and intravesical pressure during valsalva thereby decreasing or preventing leakage.
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