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510(k) Data Aggregation

    K Number
    K240798

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2024-12-17

    (270 days)

    Product Code
    Regulation Number
    884.3575
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cntrl+ Bladder Support Pessary is intended 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 subject Pessary is designed for the management of stress urinary incontinence (SUI) in women, is a device made of medical-grade Santoprene, inserted intravaginally to support the urethra. The Cntrl+ Bladder Support Pessary reduces bladder leaks in women who are suffering from SUI by preventing or reducing unwanted urinary leakage. Use of the Cntrl+ Bladder Support Pessary is applicable for women who experience leakage when laughing, coughing, exercising, sneezing, etc. The shape of the pessary is designed to fit in the vaginal tract. The device fits most users; the correct size will be determined and prescribed by the physician. The Cntrl+ Bladder Support Pessary can be worn daily for up to 12 hours. The Cntrl+ Bladder Support Pessary can be reused (and cleaned) for 30-90 times.

    AI/ML Overview

    N/A

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