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

    CleanCisionTM Wound Retraction and Protection System

    K Number: DEN150038 · Decision Dec 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    491

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    Basic Information

    Device Name
    CleanCisionTM Wound Retraction and Protection System
    K Number
    DEN150038
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4371
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Prescient Surgical
    Date Received
    August 13, 2015
    Decision Date
    December 16, 2016
    Product Code
    PQI
    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
    PQI Wound Retraction And Protection System

    Similar 510(k) Clearances

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    CleanCision Wound Retraction and Protection System

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