Wovyn Depth Electrode
Device Facts
| Record ID | K253970 |
|---|---|
| Device Name | Wovyn Depth Electrode |
| Applicant | Sensomedical Labs, Ltd. |
| Product Code | GZL · Neurology |
| Decision Date | Apr 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1330 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.
