BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

    K Number: K993459 · Decision Nov 5, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    5
    Review Days
    23

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    Basic Information

    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    K Number
    K993459
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Uroscience, Inc.
    Date Received
    October 13, 1999
    Decision Date
    November 5, 1999
    Product Code
    PAG
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by Advanced Uroscience, Inc.

    K Number Device Name
    K001807 TISSUE MARKER
    K002573 ADVANCED UROSCIENCE INNERSHEATH
    K002323 ADVANCED UROSCIENCE INJECTION NEEDLE
    K982890 ADVANCED UROSCIENCE INJECTION NEEDLE