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

    ConvertX Nephroureteral Stent System

    K Number: K161277 · Decision Nov 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    2
    Review Days
    200

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    Basic Information

    Device Name
    ConvertX Nephroureteral Stent System
    K Number
    K161277
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brightwater Medical
    Date Received
    May 6, 2016
    Decision Date
    November 22, 2016
    Product Code
    FAD
    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
    FAD Stent, Ureteral

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    Other Clearances by Brightwater Medical

    K Number Device Name
    K181669 ConvertX Biliary Stent System