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

    ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE

    K Number: K962570 · Decision Nov 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    128
    Registration Numbers
    128
    Same Product Code
    132
    Applicant Total
    7
    Review Days
    149

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    Basic Information

    Device Name
    ISAN STERNAL-ILIAC ASPIRATION BIOPSY NEEDLE
    K Number
    K962570
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1075
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gallini Intl., Inc.
    Date Received
    July 1, 1996
    Decision Date
    November 27, 1996
    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 Gallini Intl., Inc.

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