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

    MANDREL GUIDEWIRE

    K Number: K140482 · Decision Apr 8, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    42
    Applicant Total
    16
    Review Days
    41

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    Basic Information

    Device Name
    MANDREL GUIDEWIRE
    K Number
    K140482
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lake Region Medical
    Date Received
    February 26, 2014
    Decision Date
    April 8, 2014
    Product Code
    OCY
    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
    OCY Endoscopic Guidewire, Gastroenterology-Urology

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