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

    npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™

    K Number: K201400 · Decision Aug 23, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    452

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    Basic Information

    Device Name
    npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™
    K Number
    K201400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4683
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aatru Medical, LLC
    Date Received
    May 28, 2020
    Decision Date
    August 23, 2021
    Product Code
    QPX
    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
    QPX Negative Pressure Wound Therapy, Non-Powered Suction Pump, Chemical