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

    MODEL TR RECTAL SUCTION BIOPSY TUBE

    K Number: K902097 · Decision Jul 27, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    8
    Review Days
    80

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    Basic Information

    Device Name
    MODEL TR RECTAL SUCTION BIOPSY TUBE
    K Number
    K902097
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Medical Measurements, Inc.
    Date Received
    May 8, 1990
    Decision Date
    July 27, 1990
    Product Code
    FCK
    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
    FCK Instrument, Biopsy, Suction

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