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

    ULTRAPRO Mesh and ULTRAPRO ADVANCED

    K Number: K180910 · Decision Jul 2, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    332
    Applicant Total
    2
    Review Days
    87

    Basic Information

    Device Name
    ULTRAPRO Mesh and ULTRAPRO ADVANCED
    K Number
    K180910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ethicon Inc
    Date Received
    April 6, 2018
    Decision Date
    July 2, 2018
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

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