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

    ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE

    K Number: K905282 · Decision Mar 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    46
    Applicant Total
    5
    Review Days
    116

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    Basic Information

    Device Name
    ENDOSCOPIC ACCESSORY TO THE LIGHT SOURCE
    K Number
    K905282
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Frantz Medical Development, Ltd.
    Date Received
    November 23, 1990
    Decision Date
    March 19, 1991
    Product Code
    GCT
    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
    GCT Light Source, Endoscope, Xenon Arc

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