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510(k) Data Aggregation

    K Number
    K083769
    Device Name
    MODIFICATION TO URESTA PESSARY
    Manufacturer
    EASTMED INC.
    Date Cleared
    2009-01-14

    (27 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    EASTMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for use in adult women, over 18 years of age, who experience involuntary urine loss with physical activity (stress urinary incontinence).
    Device Description
    The uresta™ Pessary has been modified to be manufactured using an alternate non-latex thermoplastic elastomer rubber. No other changes have been made to the device.
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    K Number
    K081385
    Device Name
    URESTA PESSARY
    Manufacturer
    EASTMED INC.
    Date Cleared
    2008-10-09

    (146 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Why did this record match?
    Applicant Name (Manufacturer) :

    EASTMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is for the use in adult women, over 18 years of age who experience involuntary urine loss with physical activity (stress urinary incontinence).
    Device Description
    The uresta™ Pessary is designed for adult women who experience involuntary urine loss from the most common type of incontinence; stress incontinence, from physical activity such as coughing, laughing and/or exercising. uresta™ Pessary is a bell-shaped vaginal pessary with a handle at its base for easy insertion and removal. uresta™ Pessary stops leaking from the bladder by supporting the urethra. The narrow tip allows for easy insertion into the vaginal introitus. It is inserted directly into the vagina like a tampon and seats itself so that the wide base provides support to the urethra. It is made of medical grade injection moulded Santoprene (non-latex thermoplastic rubber). uresta™ Pessary is available individually in sizes1 (30 mm), 2 (34 mm), 3 (38 mm), 4 (43 mm), 5 (48 mm), 6 (52 mm). The products are sold individually, and as a kit including one each of sizes 3, 4, 5, the most commonly used sizes.
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