GYC
- Product code
- GYC
- Device name
- Electrode, Cortical
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1310
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 32 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250094 | 2025-04-14 | Neuralynx, Inc. | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim H… | |
| K242618 | 2025-03-30 | Precision Neuroscience, Corp. | Layer 7-T | FDA |
Official FDA classification page: GYC
Classification and pathway per current FDA publications. Data from openFDA (CC0).