GZL
- Product code
- GZL
- Device name
- Electrode, Depth
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.1330
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 58 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253970 | 2026-04-17 | Sensomedical Labs, Ltd. | Wovyn Depth Electrode | |
| K250363 | 2025-11-05 | Beijing Sinovation Medical Technology … | Depth Electrode (RSDE-08); Depth Electrode (RSDE-10… | |
| K250601 | 2025-03-30 | Alpha Omega Engineering , Ltd. | Neuro Omega System; NeuroSmart System |
Official FDA classification page: GZL
Classification and pathway per current FDA publications. Data from openFDA (CC0).