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

    GENICON TROCAR

    K Number: K982472 · Decision Feb 4, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    378
    Registration Numbers
    378
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    204

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    Basic Information

    Device Name
    GENICON TROCAR
    K Number
    K982472
    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
    Genicon, LC
    Date Received
    July 15, 1998
    Decision Date
    February 4, 1999
    Product Code
    GEA
    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
    GEA Cannula, Surgical, General & Plastic Surgery

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