510(k) K253970 ยท GZL Electrode, Depth
Wovyn Depth Electrode
| Applicant | Sensomedical Labs, Ltd., Nazareth, IL |
| Decision | Substantially Equivalent, Apr 17, 2026 |
| Received | Dec 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253970
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.