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

    INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN

    K Number: K896933 · Decision Jun 22, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    2
    Review Days
    193

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    Basic Information

    Device Name
    INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE GUN
    K Number
    K896933
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    The Witmoore Group, Inc.
    Date Received
    December 11, 1989
    Decision Date
    June 22, 1990
    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 The Witmoore Group, Inc.

    K Number Device Name
    K896932 INGRESS TECHNOLOGIES AUTO BX BIOPSY NEEDLE