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510(k) Data Aggregation

    K Number
    K974115
    Device Name
    PELVX RING, PELVX RING WITH SUPPORT
    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 RING, PELVX RING WITH SUPPORT

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

    The PelvX Ring Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse.

    The PelvX Ring with Support Vaginal Pessary is a vaginal pessary intended for support of 1st and 2nd degree prolapse combined with mild cystocele.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the PelvX Ring Vaginal Pessary and PelvX Ring with Support Vaginal Pessary, indicating that the device has been found substantially equivalent to predicate devices. It outlines the regulatory classification, indications for use, and general responsibilities but does not detail performance criteria or associated studies.

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