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    K Number
    K014246
    Device Name
    AVID-NIT NERVE STIMULATION NEEDLES
    Manufacturer
    AVID N.I.T., INC.
    Date Cleared
    2002-07-16

    (202 days)

    Product Code
    CAZ
    Regulation Number
    868.5140
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AVID-NIT NERVE STIMULATION NEEDLES

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

    The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug. These needles are to be used with battery powered periphera1 nerve locators only. These needles are specifically not intended for nerve stimulation for purposes other than nerve location. These needles are specifically not intended for neurolytic ablation.

    Device Description

    The AVID-NIT Nerve Stimulation Needles consist of an insulated hollow needles intended for locating peripheral nerves by electrical stimulation, and for the single shot administration of a local anesthetic drug.

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA regarding the AVID-NIT Nerve Stimulation Needles. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

    The letter confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. It outlines regulatory requirements that the manufacturer must comply with, but it does not detail any performance studies, test sets, ground truth, or expert involvement as requested in your prompt.

    Therefore, I cannot provide the information requested in your prompt based on the provided document.

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