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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: GYC FDA class 2

    Electrode, Cortical

    Neurology

    View full classification →

    The Cortical Electrode is a recording electrode placed directly on the surface of the cerebral cortex, used during intraoperative neurophysiological monitoring or electrocorticography to map brain function and identify epileptic foci. It is classified as a Class 2 device (moderate risk), requiring 510(k) premarket notification. The product code is GYC under regulation 21 CFR 882.1310 in the Neurology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    32 matches
    K Number
    Device Name
    Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014)
    Layer 7-T
    WISE Cortical Strip (WCS)
    Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid
    Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
    Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)
    Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode
    NeuroOne Cortical Electrode
    AirRay Subdural Cortical Electrodes
    SD LTM STIM Cortical Stimulator
    g.Estim PRO
    Cervello STIM
    MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT)
    INTEGRA ELECTRODE TUNNELING NEEDLE
    S12X WITH ESAX OPTION
    PMT SUBDURAL CORTICAL ELECTRODES
    NICOLET CORTICAL STIMULATOR
    AURAGEN CORTICAL SURFACE ELECTRODES
    DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES
    SUBDURAL STRIP ELECTRODE
    CORTICAL MAPPING UNIT, MODEL CMU
    EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI
    AD-TECH SUBDURAL ELECTRODE
    STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE
    CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON
    THE WESTERN CORTICAL ELECTRODE ARRAY
    OJEMANN CORTICAL STIMULATOR
    AD-TECH SUB DURAL ELECTRODEDS
    AD-TECH EPIDURAL PEG ELECTRODE
    NICOLET EPIDURAL SPINAL ELECTRODE
    WYLER SUBDURAL STRIP ELECTRODE
    ELECTRODE FOR NEUROLOGICAL SURGERY 2111

    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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