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

    VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT

    K Number: K981591 · Decision Oct 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    5
    Review Days
    158

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    Basic Information

    Device Name
    VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE LOOP STENT
    K Number
    K981591
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    International Regulatory Consultants
    Date Received
    May 4, 1998
    Decision Date
    October 9, 1998
    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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