BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

    K Number: K151308 · Decision Feb 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    9
    Applicant Total
    12
    Review Days
    267

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    Basic Information

    Device Name
    Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set
    K Number
    K151308
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Schoelly Fiberoptic GmbH
    Date Received
    May 18, 2015
    Decision Date
    February 9, 2016
    Product Code
    FGA
    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
    FGA Kit, Nephroscope

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