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510(k) Data Aggregation

    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?
    Applicant Name (Manufacturer) :

    INSIGHT MEDICAL CORP.

    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
    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?
    Applicant Name (Manufacturer) :

    INSIGHT MEDICAL CORP.

    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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