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

    pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent

    K Number: K163068 · Decision Dec 22, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    3
    Review Days
    50

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    Basic Information

    Device Name
    pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
    K Number
    K163068
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Q Urological Corporation
    Date Received
    November 2, 2016
    Decision Date
    December 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 Q Urological Corporation

    K Number Device Name
    K172289 pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
    K082805 PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX