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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: GWF FDA class 2

    Stimulator, Electrical, Evoked Response

    Neurology

    View full classification →

    The Stimulator, Electrical, Evoked Response is a neurological diagnostic device that delivers controlled electrical stimuli to peripheral nerves or sensory receptors to elicit evoked potentials, which are used to evaluate the integrity of sensory pathways in the nervous system. It is an FDA Class 2 device requiring 510(k) premarket notification to demonstrate substantial equivalence. Regulated under 21 CFR 882.1870 with product code GWF in the Neurology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Nicolet EDX
    Natus Ultrapro S100 (982A0594)
    Delphi Stimulator
    SafeOp 3: Neural Informatix Systeem
    MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)
    ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
    Cadwell Guardian
    SafeOp 2: Neural Informatix System
    ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress
    MEGA-TMS
    Neuro-IOM system with Neuro-IOM.NET software
    NIM Vital, Nerve Integrity Monitor
    The EPAD 2 System
    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software
    MEP Monitor
    Cascade IOMAX Intraoperative Monitor
    MagPro R20
    STM 9000 Basic, STM 9000 Standard, STM 9000 Fast, STM 9000 Ultra-Fast
    Neuromaster G1 MEE200
    EPAD
    MAGSTIM DOUBLE 70-2 COIL
    NEUROEPG SYSTEM
    SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION
    MEB-2300A NEUROPACK EVOKED POTENTIAL AND EMG MEASURING SYSTEM
    NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM 4, NEXSTIM NBS SYSTEM 4 WITH NEXSPEECH(TM)
    CAREFUSION NICOLET EDX
    CAREFUSION NICOLET EDX
    C2 NERVEMONITOR SYSTEM WITH ACCESSORIES
    NEUROVISION NERVE LOCATOR MONITOR
    PROTEKTOR 32
    MODIFCATION TO: NUVASIVE NEUROVISION EMG ENDOTRACHEAL TUBE
    MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION
    NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
    NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM
    NUVASIVE NEURO VISION SYSTEM
    EVOX ELECTRO DIAGNOSTIC DEVICE
    NIM 3.0
    MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00
    SEN-4100 ELECTRIC STIMULATOR
    NEUROVISION JJB SYSTEM
    COILS, MODELS MCF-B65, MCF-75, MCF-125 AND COOL-B65
    MODIFICATION TO NUVASIVE NEUROVISION JJB SYSTEM
    ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TCD AND VASCULAR DOPPLER; CARDIOMON
    MAGPRO, MODEL R30
    MAGSTIM 200-2
    ORTHOMON
    MAGSTIM RAPID2, MAGSTIM SUPER RAPID2, MODELS 3004-000, 3005-00
    DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH
    MEE-1000A NEUROMASTER
    ECLIPSE NEUROLOGICAL WORKSTATION

    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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