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

    STRYKER URETERAL ILLUMINATOR SYSTEM III

    K Number: K982542 · Decision Sep 22, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    9
    Applicant Total
    92
    Review Days
    63

    Basic Information

    Device Name
    STRYKER URETERAL ILLUMINATOR SYSTEM III
    K Number
    K982542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4020
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Endoscopy
    Date Received
    July 21, 1998
    Decision Date
    September 22, 1998
    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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