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510(k) Data Aggregation

    K Number
    K974116
    Device Name
    PELVX INCONTINENCE RING
    Manufacturer
    DESCHUTES MEDICAL PRODUCTS, INC.
    Date Cleared
    1998-04-27

    (178 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PELVX INCONTINENCE RING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PelvX Incontinence Ring Vaginal Pessary is a vaginal pessary intended for treatment of of a sourinary incontinence.

    Device Description

    PelvX Incontinence Ring Vaginal Pessary

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for the PelvX Incontinence Ring Vaginal Pessary. It confirms substantial equivalence to a predicate device for the treatment of urinary incontinence. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study that proves it meets them based on the text provided. This letter is a regulatory approval, not a scientific study report.

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