BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Scope ProTech

    K Number: K191011 · Decision May 7, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    21

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    Basic Information

    Device Name
    Scope ProTech
    K Number
    K191011
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meditech Endoscopy, Ltd.
    Date Received
    April 16, 2019
    Decision Date
    May 7, 2019
    Product Code
    OCU
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCU Endoscopic Storage Cover

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