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510(k) Data Aggregation

    K Number
    K233548
    Device Name
    Uresta®
    Manufacturer
    Resilia Inc.
    Date Cleared
    2024-04-03

    (152 days)

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

    Resilia Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence (involuntary urine loss, such as a pee leak that occurs when you cough, laugh, sneeze or with some physical tasks).
    Device Description
    Uresta® is a bell-shaped vaginal bladder support that is intended to support the urethra to help reduce leaks caused by stress urinary incontinence. It has a tapered tip for insertion into the vaginal introitus and a handle end to enable placement and removal. It may also be used with a water-based lubricant for easier insertion. Uresta® is available in five (5) sizes, ranging from 34 mm (size 2) to 52 mm (size 6). It can be inserted in the morning and removed at bedtime every day or used just for specific activities such as exercise and removed after the activity. Uresta® is molded from non-latex thermoplastic rubber and is provided non-sterile for single patient use.
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