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

    COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)

    K Number: K760452 · Decision Aug 30, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    111
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
    K Number
    K760452
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    August 16, 1976
    Decision Date
    August 30, 1976
    Product Code
    FDF
    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
    FDF Colonoscope And Accessories, Flexible/Rigid

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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
    K803214 ACMI BIPOLAR HEMOSTATIC ELECTRODE
    K791182 ACMI RIGI-FLEX NEPHORSCOPE
    K770754 DUODENOSCOPE, MOLEL TX-6
    K760822 MODEL TX-8 PANENDOSCOPE
    K760451 AIR WATER SOURCE (ACMI MODEL 710)