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

    Ureteral Dilators and Percutaneous Nephrostomy Dilators

    K Number: K170531 · Decision Aug 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    55
    Applicant Total
    20
    Review Days
    176

    Basic Information

    Device Name
    Ureteral Dilators and Percutaneous Nephrostomy Dilators
    K Number
    K170531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast Corp
    Date Received
    February 22, 2017
    Decision Date
    August 17, 2017
    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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