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

    GABRIEL URETERAL ILLUMINATOR SYSTEM II

    K Number: K945088 · Decision Feb 7, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    9
    Applicant Total
    5
    Review Days
    113

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    Basic Information

    Device Name
    GABRIEL URETERAL ILLUMINATOR SYSTEM II
    K Number
    K945088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gabriel Medical, Inc.
    Date Received
    October 17, 1994
    Decision Date
    February 7, 1995
    Product Code
    FCS
    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
    FCS Light, Catheter, Fiberoptic, Glass, Ureteral

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