BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    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

    K Number: K203716 · Decision Dec 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    358

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    Basic Information

    Device Name
    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
    K Number
    K203716
    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
    Smith and Nephew Medical Limited
    Date Received
    December 21, 2020
    Decision Date
    December 14, 2021
    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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