BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VENX REVOLUTION

    K Number: K110355 · Decision Apr 22, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    97
    Registration Numbers
    97
    Same Product Code
    6
    Applicant Total
    1
    Review Days
    74

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    Basic Information

    Device Name
    VENX REVOLUTION
    K Number
    K110355
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Venx, LLC
    Date Received
    February 7, 2011
    Decision Date
    April 22, 2011
    Product Code
    GAH
    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
    GAH Stylet, Surgical, General & Plastic Surgery

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