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

    URETERAL CATHETER

    K Number: K923729 · Decision Dec 7, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    27
    Applicant Total
    104
    Review Days
    498

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    Basic Information

    Device Name
    URETERAL CATHETER
    K Number
    K923729
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5130
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    July 27, 1992
    Decision Date
    December 7, 1993
    Product Code
    EYB
    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
    EYB Catheter, Ureteral, Gastro-Urology

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