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

    HERNIAMESH T-SLING

    K Number: K020652 · Decision May 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    2
    Review Days
    76

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    Basic Information

    Device Name
    HERNIAMESH T-SLING
    K Number
    K020652
    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
    Herniamesh
    Date Received
    February 28, 2002
    Decision Date
    May 15, 2002
    Product Code
    PAH
    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
    PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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    Other Clearances by Herniamesh

    K Number Device Name
    K973955 HERNIAMESH SURGICAL MESHES