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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: GZL FDA class 2

    Electrode, Depth

    Neurology

    View full classification →

    The Depth Electrode is a multi-contact electrode designed for stereotactic implantation deep into brain tissue to record electrical activity from specific brain structures, most commonly used in the presurgical evaluation of patients with drug-resistant epilepsy. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GZL under regulation 21 CFR 882.1330 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Neuro Omega System; NeuroSmart System
    Anchor Bolts as Accessories to Depth Electrodes
    Spencer Probe Depth Electrodes
    SENSOSEEG Depth Electrodes
    iCE-SG2 Subcutaneous Electrode Kit
    Evo® sEEG System
    Neuro Omega System, NeuroSmart System
    DIXI Medical Microdeep Micro-Macro Depth Electrodes
    Evo sEEG System
    iCE-SG Subcutaneous Electrode Arrays
    Sterile LeadConfirm
    microTargeting Guideline 4000 5.0 System
    Anchor Bolt (as an accessory to Depth Electrodes)
    NeuroNav System, NeuroSmart System
    Neuro Omega System
    DIXI Medical Microdeep Depth Electrode
    AccuPoint Electrode
    Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
    PMT Platinum Depthalon Depth Electrode
    DNAP Electrode
    LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM
    NEURO OMEGA SYSTEM
    STERILE DISPOSABLES FOR MER
    NEUROPORT CORTICAL MICROELECTRODE ARRAY SYSTEM
    NAVIGATION PROBES
    NEURONAV SYSTEM AND NEURONAV DRIVE
    NEUROPORT ELECTRODE
    MICROTARGETING GUIDELINE 4000
    DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES
    NEUROPROBES
    NEURODRIVE SYSTEM
    NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM
    ISIS MER SYSTEM/ELEKTA MER SYSTEM
    MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
    MACRO-MICRO DEPTH ELECTRODE
    PMT SPHENOIDAL ELECTRODE AND ACCESSORY, MODEL 2101-31 AND 2102-31 SERIES
    MICRO TARGETING ELECTRODE
    RECORDING AND STIMULATING ELECTRODE
    MICROTARGETING ELECTRODE
    NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
    AD-TECH'S FORAMEN OVALE ELECTRODE
    MICROELECTROENCEPHALOGRAPHY PROFESSIONAL SYSTEM 5000 (EEG PRO SYSTEM 5000)
    NEUROMAP
    PALI-TRODE
    AD-TECH'S SPINAL ELECTRODE
    GUIDELINE SYSTEM
    AD-TECH'S DEPTH ELECTRODE
    PMT ACCESSORY DEPTHALON ELECTRODE ANCHOR BOLT (2103-23-XX)
    TENS-IT, FITTRONIC II, (MORE LATER)
    CUEVA CRANIAL NERVE ELECTRODE

    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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