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

    QUICK CORE II

    K Number: K941256 · Decision Jul 13, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    5
    Review Days
    121

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    Basic Information

    Device Name
    QUICK CORE II
    K Number
    K941256
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Proact, Ltd.
    Date Received
    March 14, 1994
    Decision Date
    July 13, 1994
    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 Proact, Ltd.

    K Number Device Name
    K926559 PROACT BIOPSY NEEDLE ENCHANCEMENTS
    K913306 BONE-TEMNO/STERNUM-TEMNO
    K902320 BAUER FLEXI-TEMNO BIOPSY NEEDLE
    K902319 BAUER TEMNO BIOPSY NEEDLE