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

    UROSURGE SPIRALFLO URETERAL STENT

    K Number: K992391 · Decision Aug 18, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    UROSURGE SPIRALFLO URETERAL STENT
    K Number
    K992391
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Urosurge, Inc.
    Date Received
    July 19, 1999
    Decision Date
    August 18, 1999
    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 Urosurge, Inc.

    K Number Device Name
    DEN000002 UROSURGE PERCUTANEOUS SANS (STOLLER AFFERENT NERVE STIMULATOR) DEVICE
    K981491 UROSURGE FILASTENT URETERAL STENT
    K981489 UROSURGE SPIRASTENT PLUS URETERAL STENT