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

    HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L

    K Number: K090980 · Decision Jun 29, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    8
    Applicant Total
    43
    Review Days
    83

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    Basic Information

    Device Name
    HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
    K Number
    K090980
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Winter & Ibe GmbH
    Date Received
    April 7, 2009
    Decision Date
    June 29, 2009
    Product Code
    NWB
    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
    NWB Endoscope, Accessories, Narrow Band Spectrum

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