K250363 is an FDA 510(k) clearance for the Depth Electrode (RSDE-08). This device is classified as a Electrode, Depth (Class II - Special Controls, product code GZL).
Submitted by Beijing Sinovation Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on November 5, 2025, 268 days after receiving the submission on February 10, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1330.
| 510(k) Number | K250363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2025 |
| Decision Date | November 05, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZL - Electrode, Depth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1330 |