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    K Number
    K231786
    Device Name
    Gynethotics™ Pessary
    Manufacturer
    Cosm Medical
    Date Cleared
    2024-03-06

    (260 days)

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

    Cosm Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gynethotics pessaries are removable devices placed in the vaginal cavity to provide a nonsurgical alternative for the treatment of pelvic organ prolapse and to relieve the symptoms of pelvic relaxation with or without urinary incontinence in adults. Gynethotics Ring Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Support Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse. Gynethotics Ring with Knob Pessary is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Ring with Support and Knob is indicated for use in cases of mild (Stage I) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Incontinence Ring Pessary is indicated for use in cases of stress urinary incontinence. Gynethotics Marland Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Marland with Support Pessary is indicated for use in cases of mild (Stage I) and moderate (Stage II) pelvic organ prolapse, and stress urinary incontinence. Gynethotics Gellhorn Pessary is indicated for use in cases of mild (Stage I) to severe (Stage III or procidentia) pelvic organ prolapse. Gynethotics Cube Pessary is indicated for use in cases of moderate (Stage II) to severe (Stage III or procidentia) pelvic organ prolapse.
    Device Description
    Gynethotics pessaries are vaginal pessaries made from silicone that are inserted into the vagina to function as a supportive structure of the vagina, uterus, bladder and/or rectum to manage and treat the symptoms of pelvic floor dysfunction, such as pelvic organ prolapse and incontinence. Gynethotics pessaries come in four general shapes, including: Ring, Gellhorn, Marland, and Cube. Each shape comes in a range of configurable features and dimensions.
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