GYC — Electrode, Cortical Class II
FDA product code GYC covers "Electrode, Cortical", a Class II medical device regulated under 21 CFR 882.1310. Submissions are reviewed by the Neurology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GYC
- Device Class
- Class II
- Regulation Number
- 882.1310
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250094 | neuralynx | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601 | April 14, 2025 |
| K242618 | precision neuroscience | Layer 7-T | March 30, 2025 |
| K221123 | wise | WISE Cortical Strip (WCS) | November 22, 2022 |
| K211954 | spes medica | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi- | November 10, 2022 |
| K201931 | dixi medical | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | October 2, 2021 |
| K191346 | blackrock microsystems | Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) | February 14, 2020 |
| K191186 | ad-tech medical instrument corporation | Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid | January 25, 2020 |
| K192764 | neuroone | NeuroOne Cortical Electrode | November 26, 2019 |
| K183437 | cortec | AirRay Subdural Cortical Electrodes | March 12, 2019 |
| K180761 | micromed | SD LTM STIM Cortical Stimulator | June 18, 2018 |
| K173684 | g.tec medical engineering | g.Estim PRO | May 4, 2018 |
| K151354 | blackrock neuromed | Cervello STIM | January 27, 2016 |
| K110410 | nihon kohden | MS-120BK ELECTRIC STIMULATOR (EXTENSION UNIT) | August 4, 2011 |
| K102802 | integra lifesciences corporation | INTEGRA ELECTRODE TUNNELING NEEDLE | November 23, 2010 |
| K082629 | chatten associates | S12X WITH ESAX OPTION | July 1, 2009 |
| K082474 | pmt | PMT SUBDURAL CORTICAL ELECTRODES | May 8, 2009 |
| K072964 | cardinal health | NICOLET CORTICAL STIMULATOR | December 30, 2008 |
| K082250 | integra neurosciences | AURAGEN CORTICAL SURFACE ELECTRODES | October 10, 2008 |
| K053363 | ad-tech medical instrument | DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRA | May 30, 2006 |
| K021144 | nicolet biomedical | SUBDURAL STRIP ELECTRODE | June 24, 2002 |