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

    Prevena Plus 125 Therapy Unit

    K Number: K223263 · Decision Feb 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    112

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    Basic Information

    Device Name
    Prevena Plus 125 Therapy Unit
    K Number
    K223263
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4783
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M
    Date Received
    October 24, 2022
    Decision Date
    February 13, 2023
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QFC), ordered by most recent decision date.

    PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PREVENA 125 and PREVENA PLUS 125 Therapy Units

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

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