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

    MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191

    K Number: K100807 · Decision Jun 7, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    19
    Applicant Total
    72
    Review Days
    77

    Basic Information

    Device Name
    MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
    K Number
    K100807
    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
    AMERICAN MEDICAL SYSTEMS, INC.
    Date Received
    March 22, 2010
    Decision Date
    June 7, 2010
    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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