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510(k) Data Aggregation

    K Number
    K062549
    Device Name
    XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
    Manufacturer
    EXCEL TECH. LTD.
    Date Cleared
    2006-10-04

    (35 days)

    Product Code
    ETN
    Regulation Number
    874.1820
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The XLTEK Stimulator Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

    The probes are sterile and are for single patient use only.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA to Excel-Tech Ltd for their XLTEK Stimulator Probes. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any of the other specific details requested in your prompt.

    The document is a regulatory approval letter based on the claim of substantial equivalence, not a detailed report of a performance study. Therefore, I cannot extract the information you are looking for from this text.

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