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

    Universa Firm Ureteral Stents and Stent Sets

    K Number: K161236 · Decision Jan 27, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    119
    Applicant Total
    52
    Review Days
    270

    Basic Information

    Device Name
    Universa Firm Ureteral Stents and Stent Sets
    K Number
    K161236
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    COOK INCORPORATED
    Date Received
    May 2, 2016
    Decision Date
    January 27, 2017
    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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