FDA product code GYC: Electrode, Cortical
GYC is the FDA product code for electrode, cortical. It is a Class II device, regulated under 21 CFR 882.1310 and reviewed by the Neurology panel. FDA has cleared 32 510(k) submissions under GYC, 4 in the last five years, from 24 different applicants. The average 510(k) review took 214 days (median 194); 149 days on average over the last three years. FDA has posted 6 recalls for GYC devices.
Classification
| Field | Value |
|---|---|
| Device name | Electrode, Cortical |
| Device class | Class II |
| Regulation | 21 CFR 882.1310 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for GYC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 120 |
| 2019 | 2 | 74 |
| 2020 | 2 | 268 |
| 2021 | 1 | 446 |
| 2022 | 2 | 362 |
| 2025 | 2 | 149 |
Compare with all 510(k) review times · Search every GYC clearance
Top GYC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ad-Tech Medical Instrument Corp | 6 | 2006-05-30 |
| Radionics, Inc. | 3 | 1997-08-18 |
| Pmt Corp. | 2 | 2009-05-08 |
| Neuralynx, Inc. | 1 | 2025-04-14 |
| Precision Neuroscience, Corp. | 1 | 2025-03-30 |
19 more applicants have GYC clearances. See the full list in Caduvo.
Most recent GYC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K250094 | Neuralynx, Inc. | 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) | 2025-04-14 | 90 |
| K242618 | Precision Neuroscience, Corp. | Layer 7-T | 2025-03-30 | 208 |
| K221123 | Wise S.R.L. | WISE Cortical Strip (WCS) | 2022-11-22 | 218 |
| K211954 | Spes Medica Srl | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | 2022-11-10 | 505 |
| K201931 | Dixi Medical | Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) | 2021-10-02 | 446 |
Recalls for GYC devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-06-18.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code GYC?
GYC is the FDA product code for electrode, cortical. It is a Class II device, regulated under 21 CFR 882.1310 and reviewed by the Neurology panel.
What device class is GYC?
Class II, regulation 21 CFR 882.1310. Typical premarket route: 510(k).
How long does a 510(k) take for product code GYC?
Across 32 cleared submissions the average was 214 days from receipt to decision (median 194).
Which companies have the most GYC clearances?
Ad-Tech Medical Instrument Corp (6); Radionics, Inc. (3); Pmt Corp. (2); Neuralynx, Inc. (1); Precision Neuroscience, Corp. (1).
Have GYC devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2019-06-18.
Next steps
- Run an FDA pathway report with predicate devices for product code GYC
- Run a recall and safety report across every GYC manufacturer
- Watch product code GYC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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