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

    BAUER TEMNO BIOPSY NEEDLE

    K Number: K902319 · Decision Sep 6, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    BAUER TEMNO BIOPSY NEEDLE
    K Number
    K902319
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Proact, Ltd.
    Date Received
    May 23, 1990
    Decision Date
    September 6, 1990
    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 Proact, Ltd.

    K Number Device Name
    K941256 QUICK CORE II
    K926559 PROACT BIOPSY NEEDLE ENCHANCEMENTS
    K913306 BONE-TEMNO/STERNUM-TEMNO
    K902320 BAUER FLEXI-TEMNO BIOPSY NEEDLE