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

    PREVENA 125 and PREVENA PLUS 125 Therapy Units

    K Number: DEN180013 · Decision Apr 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    28
    Review Days
    400

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    Basic Information

    Device Name
    PREVENA 125 and PREVENA PLUS 125 Therapy Units
    K Number
    DEN180013
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4783
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Kci USA, Inc.
    Date Received
    March 15, 2018
    Decision Date
    April 19, 2019
    Product Code
    QFC
    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
    QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications

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    FDA Class 2 ·General, Plastic Surgery
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    Other Clearances by Kci USA, Inc.

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    K201571 ACTIV.A.C. Negative Pressure Wound Therapy System
    K200390 V.A.C. DERMATAC Drape
    K190697 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
    K181505 V.A.C. DERMATAC Drape
    K183543 ACTIV.A.C. Therapy Unit
    K181507 PREVENA RESTOR(TM) Incision Management System
    K180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System
    K173426 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
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