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

    PREVENA RESTOR(TM) Incision Management System

    K Number: K181507 · Decision Feb 15, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    96
    Registration Numbers
    96
    Same Product Code
    204
    Applicant Total
    9
    Review Days
    253

    Basic Information

    Device Name
    PREVENA RESTOR(TM) Incision Management System
    K Number
    K181507
    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.
    Date Received
    June 7, 2018
    Decision Date
    February 15, 2019
    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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    Other Clearances by KCI USA, Inc.

    K Number Device Name
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    DEN180013 PREVENA 125 and PREVENA PLUS 125 Therapy Units
    K181505 V.A.C. DERMATAC Drape
    K183543 ACTIV.A.C. Therapy Unit
    K180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
    K173447 V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
    K160487 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System