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

    NEO ERCP GUIDEWIRE

    K Number: K123439 · Decision Jan 3, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    42
    Applicant Total
    21
    Review Days
    56

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    Basic Information

    Device Name
    NEO ERCP GUIDEWIRE
    K Number
    K123439
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neometrics, Inc.
    Date Received
    November 8, 2012
    Decision Date
    January 3, 2013
    Product Code
    OCY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCY Endoscopic Guidewire, Gastroenterology-Urology

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