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

    PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings

    K Number: K161897 · Decision Oct 4, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    12
    Review Days
    85

    Basic Information

    Device Name
    PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
    K Number
    K161897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    KCI USA, INC. (KINETIC CONCEPTS, INC.)
    Date Received
    July 11, 2016
    Decision Date
    October 4, 2016
    Product Code
    OMP
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OMP Negative Pressure Wound Therapy Powered Suction Pump

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