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

    GIS ENDOSCOPIC OPTICAL LENS

    K Number: K140295 · Decision Jul 24, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    74
    Applicant Total
    2
    Review Days
    168

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    Basic Information

    Device Name
    GIS ENDOSCOPIC OPTICAL LENS
    K Number
    K140295
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Gi Scientific, LLC
    Date Received
    February 6, 2014
    Decision Date
    July 24, 2014
    Product Code
    FDS
    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
    FDS Gastroscope And Accessories, Flexible/Rigid

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    Other Clearances by Gi Scientific, LLC

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