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

    AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE

    K Number: K111118 · Decision Jul 1, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    30
    Applicant Total
    10
    Review Days
    71

    Basic Information

    Device Name
    AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K Number
    K111118
    Device Class
    FDA class 3
    Clearance Type
    Special
    Regulation Number
    884.5980
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    AMERICAN MEDICAL SYSTEMS
    Date Received
    April 21, 2011
    Decision Date
    July 1, 2011
    Product Code
    OTP
    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
    OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

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    Other Clearances by AMERICAN MEDICAL SYSTEMS

    K Number Device Name
    K140679 SUREFLEX LITHOTRIPSY LASER FIBERS
    K131229 SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
    K121805 AMS LARGE PORE POLYPROPHLENE MESH
    K121641 MINIARC PRO SINGLE-INCISION SLING SYSTEM
    K121612 ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION
    K120870 GREENLIGHT MOXY FIBER OPTIC
    K100746 FIBER ONE
    K082387 APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM
    K081710 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE