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

    SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS

    K Number: K131229 · Decision Dec 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    64
    Applicant Total
    10
    Review Days
    219

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    Basic Information

    Device Name
    SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
    K Number
    K131229
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems
    Date Received
    April 30, 2013
    Decision Date
    December 5, 2013
    Product Code
    OTN
    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
    OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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    Other Clearances by American Medical Systems

    K Number Device Name
    K140679 SUREFLEX LITHOTRIPSY LASER FIBERS
    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
    K111118 AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    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