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510(k) Data Aggregation

    K Number
    K982403
    Device Name
    BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    Manufacturer
    BRENNEN MEDICAL, INC.
    Date Cleared
    1998-09-22

    (74 days)

    Product Code
    PAG
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K030460,K993459
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Brennen Biosynthetic Surgical Mesh is indicated in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female winary incontinence resulting from urethral hypermobility or sphincter deficiency.

    Device Description

    Brennen Biosynthetic Surgical Mesh Matrix

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) clearance letter from the FDA for a surgical mesh, focusing on regulatory aspects, indications for use, and legal compliance. It does not include details about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

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