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510(k) Data Aggregation

    K Number
    K010365
    Device Name
    ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
    Manufacturer
    PERSONAL PRODUCTS CO.
    Date Cleared
    2001-04-30

    (82 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Product Code :

    MNG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    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?
    Product Code :

    MNG

    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
    K974600
    Device Name
    UROMED PATCH
    Manufacturer
    UROMED CORP.
    Date Cleared
    1998-03-31

    (112 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Product Code :

    MNG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UroMed Patch is indicated for the prevention or decrease of urine leakage in women with stress urinary incontinence. The UroMed Patch is indicated for the prevention or decrease of episodes of urine leakage in women with stress urinary incontinence.
    Device Description
    The UroMed Patch is a single use, disposable foam pad that is coated on one side with an adhesive gel. The patch is worn over the urethra between times of unination. The product is intended to prevent unine form escaping the environs of the urethra, and is replaced each time the patient urinates.
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    K Number
    K974645
    Device Name
    FEMASSIST FLEXIBLE
    Manufacturer
    INSIGHT MEDICAL CORP.
    Date Cleared
    1998-02-12

    (62 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Product Code :

    MNG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
    Device Description
    The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.
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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?
    Product Code :

    MNG

    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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    K Number
    K963858
    Device Name
    FEMASSIST URINARY DEVICE
    Manufacturer
    INSIGHT MEDICAL CORP.
    Date Cleared
    1997-10-21

    (391 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Why did this record match?
    Product Code :

    MNG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FemAssist™ is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
    Device Description
    The FemAssist™ device is a small (3.5cm in diameter) cylindrical device with a short profile (2.0cm in height) designed and constructed (molded) to fit over the female urethra, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ supports and reinforces the natural action of the muscles that control urine output and prevents accidental urine loss. The female urethra is located between the vagina and the clitoris, in the center of the area about 3cm in diameter. The FemAssist™ product is place by it's own mild vacuum action.
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    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?
    Product Code :

    MNG

    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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