Electrode, Cortical
FDA product code GYC · Class II (moderate risk) · 21 CFR 882.1310 · Neurology
32510(k) clearances
0PMA approvals
6recalls
Manufacturers
- Ad-Tech Medical Instrument Corporation 7
- Radionics, Inc. 3
- Pmt Corp. 2
- Neuralynx, Inc. 1
- Progress Mankind Technology 1
- Spes Medica Srl 1
- Dixi Medical 1
- Blackrock Microsystems 1
- Neuroone, Inc. 1
- Cortec GmbH 1
- Micromed S.P.A. 1
- G.Tec Medical Engineering GmbH 1
- Blackrock Neuromed, LLC 1
- Nihon Kohden Corporation 1
- Integra LifeSciences Corp. 1
- Chatten Associates, Inc. 1
- Cardinal Health 1
- Integra Neurosciences 1
- Nicolet Biomedical, Inc. 1
- University Hospital (London) Development Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089)…GYC · Traditional | Neuralynx, Inc. | 04/14/2025SE |
| K242618 | Layer 7-TGYC · Traditional | Precision Neuroscience, Corp. | 03/30/2025SE |
| K221123 | WISE Cortical Strip (WCS)GYC · Traditional | Wise S.R.L. | 11/22/2022SE |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip…GYC · Traditional | Spes Medica Srl | 11/10/2022SE |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)GYC · Traditional | Dixi Medical | 10/02/2021SE |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids)GYC · Traditional | Blackrock Microsystems | 02/14/2020SE |
| K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid…GYC · Traditional | Ad-Tech Medical Instrument Corporation | 01/25/2020SE |
| K192764 | NeuroOne Cortical ElectrodeGYC · Traditional | Neuroone, Inc. | 11/26/2019SE |
| K183437 | AirRay Subdural Cortical ElectrodesGYC · Traditional | Cortec GmbH | 03/12/2019SE |
| K180761 | SD LTM STIM Cortical StimulatorGYC · Traditional | Micromed S.P.A. | 06/18/2018SE |
| K173684 | g.Estim PROGYC · Traditional | G.Tec Medical Engineering GmbH | 05/04/2018SE |
| K151354 | Cervello STIMGYC · Traditional | Blackrock Neuromed | 01/27/2016SE |
| K110410 | MS-120BK Electric Stimulator (Extension Unit)GYC · Traditional | Nihon Kohden Corp. | 08/04/2011SE |
| K102802 | Integra Electrode Tunneling NeedleGYC · Traditional | Integra LifeSciences Corporation | 11/23/2010SE |
| K082629 | S12X with Esax OptionGYC · Traditional | Chatten Associates, Inc. | 07/01/2009SE |
| K082474 | PMT Subdural Cortical ElectrodesGYC · Traditional | Pmt Corp. | 05/08/2009SE |
| K072964 | Nicolet Cortical StimulatorGYC · Abbreviated | Cardinal Health, Inc. | 12/30/2008SE |
| K082250 | Auragen Cortical Surface ElectrodesGYC · Special | Integra Neurosciences | 10/10/2008SE |
| K053363 | Dual-Sided Interhemispheric Subdural Electrodes, Grid Subdural Electrodes…GYC · Abbreviated | Ad-Tech Medical Instrument Corp | 05/30/2006SE |
| K021144 | Subdural Strip ElectrodeGYC · Abbreviated | Nicolet Biomedical, Inc. | 06/24/2002SE |
| K992194 | Cortical Mapping Unit, Model CmuGYC · Traditional | Ad-Tech Medical Instrument Corp | 09/13/1999SE |
| K961942 | Epidural Peg Electrode (Ep), Sphenoidal Electrode (Eds) and Foramen, Ovale Depth…GYC · Traditional | Radionics, Inc. | 08/18/1997SE |
| K970587 | Ad-Tech Subdural ElectrodeGYC · Traditional | Ad-Tech Medical Instrument Corp | 05/09/1997SE |
| K964224 | Stainless Steel Cortac Cortical ELECTRODE(2111)/PLANTINUM Cortac Cortical ElectrodeGYC · Traditional | Pmt Corp. | 03/19/1997SE |
| K926424 | Cortical Surf Epilepsy Elect Depth Elec Epilep MonGYC · Traditional | Radionics, Inc. | 11/19/1993SE |
| K923330 | The Western Cortical Electrode ArrayGYC · Traditional | University Hospital (London) Development Corp. | 11/09/1993SE |
| K924226 | Ojemann Cortical StimulatorGYC · Traditional | Radionics, Inc. | 04/21/1993SE |
| K923803 | Ad-Tech Sub Dural ElectrodedsGYC · Traditional | Ad-Tech Medical Instrument Corp | 10/23/1992SE |
| K912760 | Ad-Tech Epidural Peg ElectrodeGYC · Traditional | Ad-Tech Medical Instrument Corp | 01/15/1992SE |
| K882053 | Nicolet Epidural Spinal ElectrodeGYC · Traditional | Nicolet Instrument Corp. | 10/18/1988SE |
| K850342 | Wyler Subdural Strip ElectrodeGYC · Traditional | Ad-Tech Medical Instrument Corp | 07/30/1985SN |
| K845035 | Electrode for Neurological Surgery 2111GYC · Traditional | Progress Mankind Technology | 07/30/1985SN |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2406-2019 Class II | Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler Subdural ElectrodesSupplemental information provided with devices indicates that the subdural electrodes, depth electrodes, and… | Ad-Tech Medical Instrument Corporation | 06/18/2019Terminated |
| Z-1030-2013 Class II | Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for…If the headphone jack is in use during a surgical procedure with the OCS2 and a non-intended voltage (such… | Integra Burlington MA, Inc. | 03/18/2013Terminated |
| Z-0892-2013 Class I | Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For temporary…The microelectrodes are not flush with the silastic substrate, may contain sharp edges capable of abrading… | Ad-Tech Medical Instrument Corporation | 12/18/2012Terminated |
| Z-0801-2012 | Nicolet C64 Stimulus Switching Unit (SSU Amplifier), Catalog/ Part Numbers: 382-610800…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | CareFusion 209 Inc. | 10/05/2011Terminated |
| Z-0800-2012 | Nicolet Cortical Stimulator Control Unit, Catalog/Part Number: 982A0558 Product Usage:…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | CareFusion 209 Inc. | 10/05/2011Terminated |
| Z-0799-2012 | NicoletOne Software v 5.60.2-5.71.4 with Cortical Stimulator License, Catalog/Part…CareFusion is recalling the NicoletOne Software v5.60.2-5.71.4 used with the Cortical Stimulator Control… | CareFusion 209 Inc. | 10/05/2011Terminated |