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

    IBI

    K Number: K974440 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    207
    Registration Numbers
    207
    Same Product Code
    360
    Applicant Total
    10
    Review Days
    66

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    Basic Information

    Device Name
    IBI
    K Number
    K974440
    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 U.S., LLC
    Date Received
    November 25, 1997
    Decision Date
    January 30, 1998
    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 U.S., LLC

    K Number Device Name
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    K990716 GALLINI BYCUT NEEDLE
    K981301 SPEED-CUT AUTOMATIC BIOPSY SYSTEM
    K980676 SPIGAL NEEDLE
    K980479 QUICK-CUT AUTOMATIC BIOPSY SYSTEM
    K980248 ACRI R NEEDLE
    K973152 GALLINI ABS DEVICE
    K972266 GALLINI COAXIAL INTRODUCER