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

    VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM

    K Number: K082640 · Decision Oct 17, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    4
    Review Days
    37

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    Basic Information

    Device Name
    VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM
    K Number
    K082640
    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
    Coloplast Manufacturing Us, LLC
    Date Received
    September 10, 2008
    Decision Date
    October 17, 2008
    Product Code
    OTM
    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
    OTM Mesh, Surgical, For Stress Urinary Incontinence, Male

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    Other Clearances by Coloplast Manufacturing Us, LLC

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