FDA Product Code
FDA Product Code GYC — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.1310
510(k) Clearances — 32 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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. | 2025-04-14 | Traditional | PDF ↗ |
| K242618 | Layer 7-T | Precision Neuroscience, Corp. | 2025-03-30 | Traditional | PDF ↗ |
| K221123 | WISE Cortical Strip (WCS) | Wise S.R.L. | 2022-11-22 | Traditional | PDF ↗ |
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | Spes Medica Srl | 2022-11-10 | Traditional | PDF ↗ |
| K201931 | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | Dixi Medical | 2021-10-02 | Traditional | PDF ↗ |
| K191346 | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | Blackrock Microsystems | 2020-02-14 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K192764 | NeuroOne Cortical Electrode | Neuroone, Inc. | 2019-11-26 | Traditional | PDF ↗ |
| K183437 | AirRay Subdural Cortical Electrodes | Cortec GmbH | 2019-03-12 | Traditional | PDF ↗ |
| K180761 | SD LTM STIM Cortical Stimulator | Micromed S.P.A. | 2018-06-18 | Traditional | PDF ↗ |
| K173684 | g.Estim PRO | G.Tec Medical Engineering GmbH | 2018-05-04 | Traditional | PDF ↗ |
| K151354 | Cervello STIM | Blackrock Neuromed | 2016-01-27 | Traditional | PDF ↗ |
| K110410 | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | Nihon Kohden Corp. | 2011-08-04 | Traditional | PDF ↗ |
| K102802 | INTEGRA ELECTRODE TUNNELING NEEDLE | Integra LifeSciences Corporation | 2010-11-23 | Traditional | PDF ↗ |
| K082629 | S12X WITH ESAX OPTION | Chatten Associates, Inc. | 2009-07-01 | Traditional | PDF ↗ |
| K082474 | PMT SUBDURAL CORTICAL ELECTRODES | Pmt Corp. | 2009-05-08 | Traditional | PDF ↗ |
| K072964 | NICOLET CORTICAL STIMULATOR | Cardinal Health, Inc. | 2008-12-30 | Abbreviated | PDF ↗ |
| K082250 | AURAGEN CORTICAL SURFACE ELECTRODES | Integra Neurosciences | 2008-10-10 | Special | PDF ↗ |
| K053363 | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES | Ad-Tech Medical Instrument Corp | 2006-05-30 | Abbreviated | PDF ↗ |
| K021144 | SUBDURAL STRIP ELECTRODE | Nicolet Biomedical, Inc. | 2002-06-24 | Abbreviated | PDF ↗ |
| K992194 | CORTICAL MAPPING UNIT, MODEL CMU | Ad-Tech Medical Instrument Corp | 1999-09-13 | Traditional | PDF ↗ |
| K961942 | EPIDURAL PEG ELECTRODE (EP), SPHENOIDAL ELECTRODE (EDS) AND FORAMEN, OVALE DEPTH ELECTRODE (ED-FO) FOR EPILEPSY MONITORI | Radionics, Inc. | 1997-08-18 | Traditional | PDF ↗ |
| K970587 | AD-TECH SUBDURAL ELECTRODE | Ad-Tech Medical Instrument Corp | 1997-05-09 | Traditional | PDF ↗ |
| K964224 | STAINLESS STEEL CORTAC CORTICAL ELECTRODE(2111)/PLANTINUM CORTAC CORTICAL ELECTRODE | Pmt Corp. | 1997-03-19 | Traditional | PDF ↗ |
| K926424 | CORTICAL SURF EPILEPSY ELECT DEPTH ELEC EPILEP MON | Radionics, Inc. | 1993-11-19 | Traditional | PDF ↗ |
| K923330 | THE WESTERN CORTICAL ELECTRODE ARRAY | University Hospital (London) Development Corp. | 1993-11-09 | Traditional | PDF ↗ |
| K924226 | OJEMANN CORTICAL STIMULATOR | Radionics, Inc. | 1993-04-21 | Traditional | PDF ↗ |
| K923803 | AD-TECH SUB DURAL ELECTRODEDS | Ad-Tech Medical Instrument Corp | 1992-10-23 | Traditional | PDF ↗ |
| K912760 | AD-TECH EPIDURAL PEG ELECTRODE | Ad-Tech Medical Instrument Corp | 1992-01-15 | Traditional | PDF ↗ |
| K882053 | NICOLET EPIDURAL SPINAL ELECTRODE | Nicolet Instrument Corp. | 1988-10-18 | Traditional | PDF ↗ |
| K845035 | ELECTRODE FOR NEUROLOGICAL SURGERY 2111 | Progress Mankind Technology | 1985-07-30 | Traditional | PDF ↗ |
| K850342 | WYLER SUBDURAL STRIP ELECTRODE | Ad-Tech Medical Instrument Corp | 1985-07-30 | Traditional | PDF ↗ |
Product code GYC · Class II · Neurology. Data: openFDA.