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

    ELECTRODE, FLEXIBLE SUCTION COAGULATOR

    K Number: K130489 · Decision Apr 19, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    53

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    Basic Information

    Device Name
    ELECTRODE, FLEXIBLE SUCTION COAGULATOR
    K Number
    K130489
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optim, LLC
    Date Received
    February 25, 2013
    Decision Date
    April 19, 2013
    Product Code
    FEH
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FEH Electrode, Flexible Suction Coagulator

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