Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart B — Neurological Diagnostic Devices](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices) → [21 CFR 882.1310](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1310) → GYC — Electrode, Cortical # GYC · Electrode, Cortical _Neurology · 21 CFR 882.1310 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC ## Overview - **Product Code:** GYC - **Device Name:** Electrode, Cortical - **Regulation:** [21 CFR 882.1310](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/882.1310) - **Device Class:** 2 - **Review Panel:** [Neurology](/submissions/NE) - **3rd-party reviewable:** yes ## Identification A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250094](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K250094.md) | 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) | Neuralynx, Inc. | Apr 14, 2025 | SESE | | [K242618](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K242618.md) | Layer 7-T | Precision Neuroscience, Corp. | Mar 30, 2025 | SESE | | [K221123](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K221123.md) | WISE Cortical Strip (WCS) | Wise S.R.L. | Nov 22, 2022 | SESE | | [K211954](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K211954.md) | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | Nov 10, 2022 | SESE | | [K201931](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K201931.md) | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | Oct 2, 2021 | SESE | | [K191346](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K191346.md) | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | Feb 14, 2020 | SESE | | [K191186](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K191186.md) | 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 | Ad-Tech Medical Instrument Corporation | Jan 25, 2020 | SESE | | [K192764](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K192764.md) | NeuroOne Cortical Electrode | Neuroone, Inc. | Nov 26, 2019 | SESE | | [K183437](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K183437.md) | AirRay Subdural Cortical Electrodes | Cortec GmbH | Mar 12, 2019 | SESE | | [K180761](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K180761.md) | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | Jun 18, 2018 | SESE | | [K173684](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K173684.md) | g.Estim PRO | G.Tec Medical Engineering GmbH | May 4, 2018 | SESE | | [K151354](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K151354.md) | Cervello STIM | Blackrock Neuromed | Jan 27, 2016 | SESE | | [K110410](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K110410.md) | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | Aug 4, 2011 | SESE | | [K102802](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K102802.md) | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | Nov 23, 2010 | SESE | | [K082629](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K082629.md) | S12X WITH ESAX OPTION | Chatten Associates, Inc. | Jul 1, 2009 | SESE | | [K082474](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K082474.md) | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | May 8, 2009 | SESE | | [K072964](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K072964.md) | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | Dec 30, 2008 | SESE | | [K082250](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K082250.md) | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | Oct 10, 2008 | SESE | | [K053363](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K053363.md) | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | Ad-Tech Medical Instrument Corp | May 30, 2006 | SESE | | [K021144](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC/K021144.md) | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | Jun 24, 2002 | SESE | ## Top Applicants - Ad-Tech Medical Instrument Corp — 6 clearances - Radionics, Inc. — 3 clearances - Pmt Corp. — 2 clearances - Ad-Tech Medical Instrument Corporation — 1 clearance - Blackrock Microsystems — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GYC) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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