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

    ESTECH COBRA(R) GENESIS BIPOLAR CLAMP

    K Number: K133017 · Decision Oct 7, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    7
    Review Days
    11

    Basic Information

    Device Name
    ESTECH COBRA(R) GENESIS BIPOLAR CLAMP
    K Number
    K133017
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ESTECH, INC.
    Date Received
    September 26, 2013
    Decision Date
    October 7, 2013
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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