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

    POLYFORM SYNTHETIC MESH

    K Number: K051245 · Decision Jun 17, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    32

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    Basic Information

    Device Name
    POLYFORM SYNTHETIC MESH
    K Number
    K051245
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Proxy Biomedical , Ltd.
    Date Received
    May 16, 2005
    Decision Date
    June 17, 2005
    Product Code
    OTO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

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

    Product Code Device Name
    OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

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    Other Clearances by Proxy Biomedical , Ltd.

    K Number Device Name
    K172636 VitaMESH Macroporous PP Surgical Mesh
    K111121 VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
    K060520 VITAMESH MACROPOROUS PP SURGICAL MESH
    K052100 MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
    K050678 MOTIFMESH SOFT TISSUE PATCH