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

    ACMI BIPOLAR HEMOSTATIC SOURCE

    K Number: K812637 · Decision Oct 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    41

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    Basic Information

    Device Name
    ACMI BIPOLAR HEMOSTATIC SOURCE
    K Number
    K812637
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    September 15, 1981
    Decision Date
    October 26, 1981
    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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    K Number Device Name
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    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)