BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    XENX STONE MANAGEMENT DEVICE

    K Number: K123438 · Decision Jan 10, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    91
    Registration Numbers
    91
    Same Product Code
    42
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    XENX STONE MANAGEMENT DEVICE
    K Number
    K123438
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xenolith Medical
    Date Received
    November 8, 2012
    Decision Date
    January 10, 2013
    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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    Other Clearances by Xenolith Medical

    K Number Device Name
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