510(k) K250363 ยท GZL Electrode, Depth
Depth Electrode (RSDE-08); Depth Electrode (RSDE-10); Depth Electrode (RSDE-12); Depth Electrode (RSDE-14); Depth Electrode (RSDE-16); Depth Electrode (RSDE-16F); Depth Electrode (RSDE-08S); Depth Electrode (RSDE-10S); Depth Electrode (RSDE-12S); Depth Electrode (RSDE-14S); Depth Electrode
| Applicant | Beijing Sinovation Medical Technology Co., Ltd., Beijing, CN |
| Decision | Substantially Equivalent, Nov 5, 2025 |
| Received | Feb 10, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250363
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.