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

    PHANTOM XL INSULATED DILATORS

    K Number: K140088 · Decision Sep 25, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    34
    Applicant Total
    2
    Review Days
    254

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    Basic Information

    Device Name
    PHANTOM XL INSULATED DILATORS
    K Number
    K140088
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.1820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tedan Surgical Innovations, LLC
    Date Received
    January 14, 2014
    Decision Date
    September 25, 2014
    Product Code
    PDQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PDQ Neurosurgical Nerve Locator

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    Other Clearances by Tedan Surgical Innovations, LLC

    K Number Device Name
    K161318 Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding Systems