BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇲🇨 Monaco

    JFil Ureteral Stents, JFil Ureteral Stents ECO KIT

    K Number: K212868 · Decision Jan 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    1
    Review Days
    139

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    Basic Information

    Device Name
    JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
    K Number
    K212868
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rocamed Sam
    Date Received
    September 9, 2021
    Decision Date
    January 26, 2022
    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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