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

    SMARTGRAFT 200 SYSTEM

    K Number: K141713 · Decision Oct 28, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    39
    Applicant Total
    2
    Review Days
    125

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    Basic Information

    Device Name
    SMARTGRAFT 200 SYSTEM
    K Number
    K141713
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ingeneron, Inc.
    Date Received
    June 25, 2014
    Decision Date
    October 28, 2014
    Product Code
    MUU
    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
    MUU System, Suction, Lipoplasty

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    Other Clearances by Ingeneron, Inc.

    K Number Device Name
    K141591 SMARTGRAFT 30 SYSTEM