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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GXZ FDA class 2

    Electrode, Needle

    Neurology

    View full classification →

    The Needle Electrode is a fine-gauge electrode inserted through the skin into muscle or nerve tissue to record electrical signals for electromyography (EMG) or nerve conduction diagnostic studies. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GXZ under regulation 21 CFR 882.1350 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Subdermal Needle Electrode, Corkscrew
    Medical Disposable Sterile Needle Electrode
    Phantom XL Insulated Dilators
    Guardian Needle Electrode
    Spes Medica Subdermal Needle Electrodes
    PressOn Electrode Headset
    DMS Disposable Subdermal Needle Electrodes
    E-Shield Multi-paried Subdermal Needle Electrodes
    E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES
    MR CONDITIONAL PRESSON ELECTRODE
    DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,
    PRESSON ELECTRODE
    PRESSON ELECTRODE
    AVS ARIA NEUROMONITORING PROBE AND AVS ARIA PROBE DILATORS
    DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE
    NERVE MONITORING CABLE
    SUBDERMAL NEEDLE ELECTRODES
    DISPOSABLE PEDICLE SCREW PROBE, MODEL 3603-00
    MODIFICATION TO: AMBU NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
    DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES
    SUBDERMAL WIRE ELECTRODE, MODEL SWE
    PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
    XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382
    DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE
    AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES
    ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE
    LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
    RHYTHMLINK INTERNATIONAL SUBDERMAL NEEDLE ELECTRODES
    SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
    DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
    STERILE SUBDERMAL NEEDLE ELECTRODES
    POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE
    ACCUGUIDE MUSCLE INJECTION MONITOR
    NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
    DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
    DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19)
    PROTECTRODE SYSTEM
    AGRAM SPYRAL ELECTRODE
    EEG NEEDLE ELECTRODE
    MONOPOLAR EMG NEEDLE ELECTRODE
    CONCENTRIC EMG NEEDLE ELECTRODE
    GROUND/REFERENCE NEEDLE ELECTRODE
    PROBLOC INSULATED NEEDLES
    BIO-DETEK EEG ELECTRODE
    DISPOSABLE MONOPOLAR NEEDLE ELECTRODE
    SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
    DISPOSIBLE EEG NEEDLE ELECTRODES
    SPECIMEX DC
    DISP. CONCENTRIC NEEDLE ELECTRODE (DCP-30, DCP-45)
    LOW PROFILE NEEDLE ELECTRODE (N-SPYRAL LP)

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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