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

    GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

    K Number: K132181 · Decision Oct 21, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    12
    Review Days
    98

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    Basic Information

    Device Name
    GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
    K Number
    K132181
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Surgical Technologies America
    Date Received
    July 15, 2013
    Decision Date
    October 21, 2013
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

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