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510(k) Data Aggregation

    K Number
    K092981
    Device Name
    PANPAC VAGINAL PESSARY
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2010-07-22

    (297 days)

    Product Code
    HHW
    Regulation Number
    884.3575
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    K132313,K231786
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Panpac Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele as well as stress urinary incontinence in women.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Panpac Vaginal Pessaries". It indicates the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements.

    However, this document does NOT contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

    Therefore, I cannot fulfill your request for this specific information based on the provided text.

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