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

    TR NEEDLE

    K Number: K970871 · Decision May 21, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    7
    Review Days
    72

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    Basic Information

    Device Name
    TR NEEDLE
    K Number
    K970871
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gallini Intl., Inc.
    Date Received
    March 10, 1997
    Decision Date
    May 21, 1997
    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 Gallini Intl., Inc.

    K Number Device Name
    K970872 PAN (CHIBA ASPIRATING NEEDLE)
    K964777 TZ
    K962570 ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
    K962569 BIOMID BONE MARROW BIOPSY NEEDLE
    K962568 ACRI ILIAC CREST ASPIRATION BIOPSY NEEDLES
    K961407 SPEED-CUT