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

    ADMS SILENT NEEDLE GUN

    K Number: K882746 · Decision Mar 17, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    4
    Review Days
    255

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    Basic Information

    Device Name
    ADMS SILENT NEEDLE GUN
    K Number
    K882746
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Advanced Diagnostic Medical Systems, Inc.
    Date Received
    July 5, 1988
    Decision Date
    March 17, 1989
    Product Code
    KNW
    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
    KNW Instrument, Biopsy

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    Other Clearances by Advanced Diagnostic Medical Systems, Inc.

    K Number Device Name
    K890203 ADMS BIOPSY NEEDLE
    K881208 PROBE SHEATH FOR ADMS ULTRASOUND PROBE
    K875119 BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE