Product code GYC
- Device name
- Electrode, Cortical
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1310
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 He... | Neuralynx, Inc. | 2025-04-14 |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025-03-30 |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 2022-11-22 |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | 2022-11-10 |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | 2021-10-02 |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | 2020-02-14 |
| 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 | 2020-01-25 |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | 2019-11-26 |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | 2019-03-12 |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018-06-18 |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018-05-04 |
| K151354 | Cervello STIM | Blackrock Neuromed | 2016-01-27 |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | 2011-08-04 |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | 2010-11-23 |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | 2009-07-01 |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | 2009-05-08 |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | 2008-12-30 |
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | 2008-10-10 |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | Ad-Tech Medical Instrument Corp | 2006-05-30 |
| K021144 | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | 2002-06-24 |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | Ad-Tech Medical Instrument Corp | 1999-09-13 |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI | Radionics, Inc. | 1997-08-18 |
| K970587 | AD-TECH SUBDURAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Pmt Corp. | 1997-03-19 |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | Radionics, Inc. | 1993-11-19 |
| K923330 | THE WESTERN CORTICAL ELECTRODE ARRAY | University Hospital (London) Development Corp. | 1993-11-09 |
| K924226 | OJEMANN CORTICAL STIMULATOR | Radionics, Inc. | 1993-04-21 |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | Ad-Tech Medical Instrument Corp | 1992-10-23 |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | Ad-Tech Medical Instrument Corp | 1992-01-15 |
| K882053 | NICOLET EPIDURAL SPINAL ELECTRODE | Nicolet Instrument Corp. | 1988-10-18 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08033928120828 | Micromed | MICROMED SPA | 2018-07-02 |
| 10381780035084 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035251 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035244 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035237 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035220 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035213 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035206 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035190 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035176 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035169 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035152 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035145 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035138 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035121 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035091 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035060 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035053 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780035008 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034995 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034988 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034971 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034964 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034957 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034940 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034933 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034926 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034902 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034896 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |
| 10381780034889 | Auragen™ | INTEGRA NEUROSCIENCES IMPLANT (FRANCE) | 2016-08-08 |