BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS

    K Number: K130006 · Decision Apr 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    16
    Review Days
    93

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    Basic Information

    Device Name
    BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS
    K Number
    K130006
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Regulation Number
    884.5980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Biotech Incorporated
    Date Received
    January 2, 2013
    Decision Date
    April 5, 2013
    Product Code
    PAI
    Advisory Committee
    Obstetrics/Gynecology
    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
    PAI Mesh, Surgical, Non-Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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    K170016 Biodesign Fistula Plug
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