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510(k) Data Aggregation

    K Number
    K954215
    Device Name
    MINIGUARD
    Manufacturer
    ADVANCED SURGICAL INTERVENTION, INC.
    Date Cleared
    1996-05-08

    (243 days)

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

    ADVANCED SURGICAL INTERVENTION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.
    Device Description
    The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.
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