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

    ConvertX Biliary Stent System

    K Number: K181669 · Decision Mar 14, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    2
    Review Days
    262

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    Basic Information

    Device Name
    ConvertX Biliary Stent System
    K Number
    K181669
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Brightwater Medical
    Date Received
    June 25, 2018
    Decision Date
    March 14, 2019
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Brightwater Medical

    K Number Device Name
    K161277 ConvertX Nephroureteral Stent System