FDA 510(k) Applications for Medical Device Product Code "GYC"
(Electrode, Cortical)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K970587 | AD-TECH MEDICAL INSTRUMENT CORP. | AD-TECH SUBDURAL ELECTRODE | 05/09/1997 |
| K992194 | AD-TECH MEDICAL INSTRUMENT CORP. | CORTICAL MAPPING UNIT, MODEL CMU | 09/13/1999 |
| K053363 | AD-TECH MEDICAL INSTRUMENT CORP. | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | 05/30/2006 |
| K191186 | Ad-Tech Medical Instrument Corporation | 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 | 01/25/2020 |
| K191346 | Blackrock Microsystems | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | 02/14/2020 |
| K151354 | BLACKROCK NEUROMED | Cervello STIM | 01/27/2016 |
| K072964 | CARDINAL HEALTH, INC. | NICOLET CORTICAL STIMULATOR | 12/30/2008 |
| K082629 | CHATTEN ASSOCIATES, INC. | S12X WITH ESAX OPTION | 07/01/2009 |
| K183437 | CorTec GmbH | AirRay Subdural Cortical Electrodes | 03/12/2019 |
| K201931 | Dixi Medical | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | 10/02/2021 |
| K173684 | g.tec medical engineering GmbH | g.Estim PRO | 05/04/2018 |
| K102802 | INTEGRA LIFESCIENCES CORPORATION | INTEGRA ELECTRODE TUNNELING NEEDLE | 11/23/2010 |
| K082250 | INTEGRA NEUROSCIENCES | AURAGEN CORTICAL SURFACE ELECTRODES | 10/10/2008 |
| K180761 | micromed S.p.A. | SD LTM STIM Cortical Stimulator | 06/18/2018 |
| K192764 | NeuroOne, Inc. | NeuroOne Cortical Electrode | 11/26/2019 |
| K021144 | NICOLET BIOMEDICAL, INC. | SUBDURAL STRIP ELECTRODE | 06/24/2002 |
| K110410 | NIHON KOHDEN CORP. | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | 08/04/2011 |
| K082474 | PMT CORP. | PMT SUBDURAL CORTICAL ELECTRODES | 05/08/2009 |
| K964224 | PMT CORP. | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | 03/19/1997 |
| K961942 | RADIONICS, INC. | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI | 08/18/1997 |
| K211954 | Spes Medica SRL | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | 11/10/2022 |
| K221123 | WISE S.r.l. | WISE Cortical Strip (WCS) | 11/22/2022 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
