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

    WESTERMAN-JENSEN BIOPSY NEEDLE

    K Number: K840168 · Decision Mar 12, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    8
    Review Days
    56

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    Basic Information

    Device Name
    WESTERMAN-JENSEN BIOPSY NEEDLE
    K Number
    K840168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Popper & Sons, Inc.
    Date Received
    January 16, 1984
    Decision Date
    March 12, 1984
    Product Code
    FCG
    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
    FCG Biopsy Needle

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    Other Clearances by Popper & Sons, Inc.

    K Number Device Name
    K911397 HYPODERMIC NEEDLES, SINGLE LUMEN
    K843830 J -JAMSHIDI TYPE-BONE MARROW BIOPSY/ASPI
    K843690 ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
    K842406 WESCOTT TYPE BIOPSY NEEDLE
    K841300 ANTRUM NEEDLE-WOLF TYPE
    K841301 GARDNER TYPE BONE MARROW NEEDLE
    K841299 BIERMAN BIOPSY NEEDLE