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510(k) Data Aggregation

    K Number
    K990100
    Device Name
    POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    Manufacturer
    TE ME NA S.A.R.L.
    Date Cleared
    2000-08-02

    (576 days)

    Product Code
    GXZ
    Regulation Number
    882.1350
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE

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

    The Polymedic UPA and UPC Nerve Stimulator Needles, and the Polyplex N and Polyplex C Nerve Stimulation needle kits are intended for use in regional anesthesia procedures, by anesthesiologists or other trained professionals, for the location of peripheral nerves (when used with a nerve stimulator) and administration of anesthesia drugs.

    Device Description

    Polymedic UPA, UPC, Polyplex N, and Polyplex C Nerve Stimulation Needles

    AI/ML Overview

    I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any study details. The document is an FDA 510(k) clearance letter for nerve stimulation needles, confirming "substantial equivalence" to previously marketed devices. It does not include a scientific study report or data on performance metrics.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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