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

    RocaJJ Soft Stents

    K Number: K173734 · Decision Mar 12, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    5
    Review Days
    96

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    Basic Information

    Device Name
    RocaJJ Soft Stents
    K Number
    K173734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Promepla Sam
    Date Received
    December 6, 2017
    Decision Date
    March 12, 2018
    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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