BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020

    K Number: K091152 · Decision May 7, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    71
    Review Days
    17

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    Basic Information

    Device Name
    VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
    K Number
    K091152
    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
    Coloplast A/S
    Date Received
    April 20, 2009
    Decision Date
    May 7, 2009
    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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