Electrode, Cortical
Regulation 882.1310
0510(k)s in 12 months (32 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in GYC
| Company | 510(k)s | Recalls |
|---|---|---|
| Ad-Tech Medical Instrument Corp | 7 | 2 |
| CareFusion 209 Inc. | 0 | 3 |
| Radionics, Inc. | 3 | 0 |
| Pmt Corp. | 2 | 0 |
| Blackrock Microsystems | 1 | 0 |
| Blackrock Neuromed | 1 | 0 |
| Cardinal Health, Inc. | 1 | 0 |
| Chatten Associates, Inc. | 1 | 0 |
| Cortec GmbH | 1 | 0 |
| Dixi Medical | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 14, 2025 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601 Neuralynx, Inc. | GYC |
| Mar 30, 2025 | K242618 | Layer 7-T Precision Neuroscience, Corp. | GYC |
| Nov 22, 2022 | K221123 | WISE Cortical Strip (WCS) Wise S.R.L., IT | GYC |
| Nov 10, 2022 | K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Map Spes Medica Srl, IT | GYC |
| Oct 2, 2021 | K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) Dixi Medical, FR | GYC |
| Feb 14, 2020 | K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) Blackrock Microsystems | GYC |
| Jan 25, 2020 | K191186 | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Ad-Tech Medical Instrument Corporation | GYC |
| Nov 26, 2019 | K192764 | NeuroOne Cortical Electrode Neuroone, Inc. | GYC |
| Mar 12, 2019 | K183437 | AirRay Subdural Cortical Electrodes Cortec GmbH, DE | GYC |
| Jun 18, 2018 | K180761 | SD LTM STIM Cortical Stimulator Micromed S.P.A., IT | GYC |
| May 4, 2018 | K173684 | g.Estim PRO G.Tec Medical Engineering GmbH, AU | GYC |
| Jan 27, 2016 | K151354 | Cervello STIM Blackrock Neuromed | GYC |
| Aug 4, 2011 | K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) Nihon Kohden Corp. | GYC |
| Nov 23, 2010 | K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE Integra LifeSciences Corporation | GYC |
| Jul 1, 2009 | K082629 | S12X WITH ESAX OPTION Chatten Associates, Inc. | GYC |
| May 8, 2009 | K082474 | PMT SUBDURAL CORTICAL ELECTRODES Pmt Corp. | GYC |
| Dec 30, 2008 | K072964 | NICOLET CORTICAL STIMULATOR Cardinal Health, Inc. | GYC |
| Oct 10, 2008 | K082250 | AURAGEN CORTICAL SURFACE ELECTRODES Integra Neurosciences | GYC |
| May 30, 2006 | K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES Ad-Tech Medical Instrument Corp | GYC |
| Jun 24, 2002 | K021144 | SUBDURAL STRIP ELECTRODE Nicolet Biomedical, Inc. | GYC |
| Sep 13, 1999 | K992194 | CORTICAL MAPPING UNIT, MODEL CMU Ad-Tech Medical Instrument Corp | GYC |
| Aug 18, 1997 | K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI Radionics, Inc. | GYC |
| May 9, 1997 | K970587 | AD-TECH SUBDURAL ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
| Mar 19, 1997 | K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE Pmt Corp. | GYC |
| Nov 19, 1993 | K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON Radionics, Inc. | GYC |
| Nov 9, 1993 | K923330 | THE WESTERN CORTICAL ELECTRODE ARRAY University Hospital (London) Development Corp., CA | GYC |
| Apr 21, 1993 | K924226 | OJEMANN CORTICAL STIMULATOR Radionics, Inc. | GYC |
| Oct 23, 1992 | K923803 | AD-TECH SUB DURAL ELECTRODEDS Ad-Tech Medical Instrument Corp | GYC |
| Jan 15, 1992 | K912760 | AD-TECH EPIDURAL PEG ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
| Oct 18, 1988 | K882053 | NICOLET EPIDURAL SPINAL ELECTRODE Nicolet Instrument Corp. | GYC |
| Jul 30, 1985 | K850342 | WYLER SUBDURAL STRIP ELECTRODE Ad-Tech Medical Instrument Corp | GYC |
| Jul 30, 1985 | K845035 | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 Progress Mankind Technology | GYC |
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