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

    AMS ELEVATE PC

    K Number: K112842 · Decision Oct 25, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    30
    Applicant Total
    72
    Review Days
    26

    Basic Information

    Device Name
    AMS ELEVATE PC
    K Number
    K112842
    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, INC.
    Date Received
    September 29, 2011
    Decision Date
    October 25, 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, INC.

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    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
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    K081613 SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS
    Search all 72 clearances from AMERICAN MEDICAL SYSTEMS, INC. →