Cleared Traditional

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

K250363 · Beijing Sinovation Medical Technology Co., Ltd. · Neurology

Nov 2025

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K250363 is an FDA 510(k) clearance for 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, 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 review panel. Regulated under 21 CFR 882.1330.

Submission Details

510(k) Number	K250363 FDA.gov
FDA Decision	Cleared 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