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

    PRO-B BIOPSY NEEDLE

    K Number: K951598 · Decision Apr 21, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    PRO-B BIOPSY NEEDLE
    K Number
    K951598
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Promedical , Ltd.
    Date Received
    April 7, 1995
    Decision Date
    April 21, 1995
    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 Promedical , Ltd.

    K Number Device Name
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    K944944 CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
    K944942 BREAST LESION LOCALIZATION NEEDLE