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

    CYTOASPIRATOR

    K Number: K902910 · Decision Jan 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    12
    Applicant Total
    1
    Review Days
    198

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    Basic Information

    Device Name
    CYTOASPIRATOR
    K Number
    K902910
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    H & B Medical Technology, Inc.
    Date Received
    July 2, 1990
    Decision Date
    January 16, 1991
    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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