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510(k) Data Aggregation

    K Number
    K173351
    Device Name
    Panpac Flexi Shelf Pessary
    Manufacturer
    Panpac Medical Corporation
    Date Cleared
    2018-10-31

    (371 days)

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

    Panpac Flexi Shelf Pessary

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

    The Flexi Shelf Pessary is indicated for use as a removable structure placed in the support of a second to third degree prolapse or procidentia.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Panpac Flexi Shelf Pessary, which concerns the regulatory approval of a medical device based on its substantial equivalence to a predicate device, not on specific performance acceptance criteria and associated studies.

    Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study findings based on the provided text.

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