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

    UROSURGE UROSTENT

    K Number: K973504 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    121
    Applicant Total
    4
    Review Days
    136

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    Basic Information

    Device Name
    UROSURGE UROSTENT
    K Number
    K973504
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Princeton Regulatory Assoc.
    Date Received
    September 16, 1997
    Decision Date
    January 30, 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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    Other Clearances by Princeton Regulatory Assoc.

    K Number Device Name
    K965136 UROSURGE UROTHERM FLUID WARMING SYSTEM
    K972158 GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
    K962770 UROSURGE ACUTRAINER