GYC · Electrode, Cortical
Neurology · 21 CFR 882.1310 · Class 2
Overview
| Product Code | GYC |
|---|---|
| Device Name | Electrode, Cortical |
| Regulation | 21 CFR 882.1310 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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).
Cleared Devices (32)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250094 | 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 | Layer 7-T | Precision Neuroscience, Corp. | Mar 30, 2025 | SESE |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | Nov 22, 2022 | SESE |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | Nov 10, 2022 | SESE |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | Oct 2, 2021 | SESE |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | Feb 14, 2020 | SESE |
| K191186 | 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 | NeuroOne Cortical Electrode | Neuroone, Inc. | Nov 26, 2019 | SESE |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | Mar 12, 2019 | SESE |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | Jun 18, 2018 | SESE |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | May 4, 2018 | SESE |
| K151354 | Cervello STIM | Blackrock Neuromed | Jan 27, 2016 | SESE |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | Aug 4, 2011 | SESE |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | Nov 23, 2010 | SESE |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | Jul 1, 2009 | SESE |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | May 8, 2009 | SESE |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | Dec 30, 2008 | SESE |
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | Oct 10, 2008 | SESE |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | Ad-Tech Medical Instrument Corp | May 30, 2006 | SESE |
| K021144 | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | Jun 24, 2002 | SESE |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | Ad-Tech Medical Instrument Corp | Sep 13, 1999 | SESE |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI | Radionics, Inc. | Aug 18, 1997 | SESE |
| K970587 | AD-TECH SUBDURAL ELECTRODE | Ad-Tech Medical Instrument Corp | May 9, 1997 | SESE |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Pmt Corp. | Mar 19, 1997 | SESE |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | Radionics, Inc. | Nov 19, 1993 | SESE |
| K923330 | THE WESTERN CORTICAL ELECTRODE ARRAY | University Hospital (London) Development Corp. | Nov 9, 1993 | SESE |
| K924226 | OJEMANN CORTICAL STIMULATOR | Radionics, Inc. | Apr 21, 1993 | SESE |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | Ad-Tech Medical Instrument Corp | Oct 23, 1992 | SESE |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | Ad-Tech Medical Instrument Corp | Jan 15, 1992 | SESE |
| K882053 | NICOLET EPIDURAL SPINAL ELECTRODE | Nicolet Instrument Corp. | Oct 18, 1988 | SESE |
| K850342 | WYLER SUBDURAL STRIP ELECTRODE | Ad-Tech Medical Instrument Corp | Jul 30, 1985 | SN |
| K845035 | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 | Progress Mankind Technology | Jul 30, 1985 | SN |
Top Applicants
- Ad-Tech Medical Instrument Corp — 6 clearances
- Radionics, Inc. — 3 clearances
- Pmt Corp. — 2 clearances
- Wise S.R.L. — 1 clearance
- University Hospital (London) Development Corp. — 1 clearance
