FDA cleared the 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 (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept from Beijing Sinovation Medical Technology Co., Ltd. on Nov 5, 2025 under K250363, a traditional 510(k). The device falls under product code GZL, Electrode, Depth, regulated at 21 CFR 882.1330 as a Class 2 device. The review panel was Neurology.
FDA logged the submission as received on Feb 10, 2025. The decision came 268 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Beijing Sinovation Medical Technology Co., Ltd. in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K250363?
K250363 is the FDA 510(k) for 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 (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept, submitted by Beijing Sinovation Medical Technology Co., Ltd.. FDA's decision date was Nov 5, 2025, under product code GZL (Electrode, Depth).
Who makes the 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 (RSDE-16S); Depth Electrode (RSDE-16G); Depth Electrode (RSDE-18); Depth Electrode (RSDE-18F); Depth Electrode (RSDE-18T); Depth Electrode (RSDE-20); Depth Electrode (RSDE-20F); Dept?
Beijing Sinovation Medical Technology Co., Ltd., based in Beijing, is the applicant of record for K250363.
How long did the K250363 review take?
FDA received the submission on Feb 10, 2025 and issued its decision on Nov 5, 2025, 268 days later.