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

    ACMI BIPOLAR HEMOSTATIC ELECTRODE

    K Number: K803214 · Decision Jan 15, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    ACMI BIPOLAR HEMOSTATIC ELECTRODE
    K Number
    K803214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    December 18, 1980
    Decision Date
    January 15, 1981
    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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    Other Clearances by American Cystocope Makers, Inc.

    K Number Device Name
    K832040 STERILE FLUID PRODUCING UNIT #EP550
    K812637 ACMI BIPOLAR HEMOSTATIC SOURCE
    K811218 ACMI ASPIRATOR KIT #8808
    K791182 ACMI RIGI-FLEX NEPHORSCOPE
    K770754 DUODENOSCOPE, MOLEL TX-6
    K760822 MODEL TX-8 PANENDOSCOPE
    K760452 COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
    K760451 AIR WATER SOURCE (ACMI MODEL 710)