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

    URETERAL DOUBLE PIGTAIL STENT

    K Number: K834401 · Decision Mar 22, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    21
    Review Days
    99

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    Basic Information

    Device Name
    URETERAL DOUBLE PIGTAIL STENT
    K Number
    K834401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Hobbs Medical, Inc.
    Date Received
    December 14, 1983
    Decision Date
    March 22, 1984
    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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