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

    Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter

    K Number: K180086 · Decision Mar 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    42
    Review Days
    55

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    Basic Information

    Device Name
    Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
    K Number
    K180086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Gyrus Acmi, Inc.
    Date Received
    January 12, 2018
    Decision Date
    March 8, 2018
    Product Code
    FGE
    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
    FGE Stents, Drains And Dilators For The Biliary Ducts

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