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

    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX

    K Number: K030460 · Decision Mar 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    8
    Applicant Total
    17
    Review Days
    23

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    Basic Information

    Device Name
    MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    K Number
    K030460
    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
    Brennen Medical, Inc.
    Date Received
    February 12, 2003
    Decision Date
    March 7, 2003
    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 Brennen Medical, Inc.

    K Number Device Name
    K050086 BRENNEN MEDICAL SILVER GLUCAN WOUND DRESSING
    K021835 BRENNEN MEDICAL SURGICAL MESH, GLUCAMESH/GLUCATEX
    K002078 BETA GLUCAN GEL (MACROPRO GEL)
    K002077 GLUCANPRO CREAM
    K000518 MACROPRO GEL
    K000519 GLUCANPRO
    K982825 BRENNEN MEDICAL BETA GLUCAN GEL
    K982403 BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX
    K980962 BRENNEN MEDICAL BETA GLUCAN CREAM, MACROPRO
    K964241 BRENNEN MEDICAL GLUCAN II WOUND DRESSING
    Search all 17 clearances from Brennen Medical, Inc. →