Depth Electrode (17+ models)— 510(k) K250363

Name: FDA 510(k) clearance K250363
Creator: U.S. Food and Drug Administration
Published: 2025-11-05

Substantially Equivalent

Beijing Sinovation Medical Technology Co., Ltd.

FDA 510(k) clearance K250363 for Depth Electrode (17+ models), Substantially Equivalent on 2025-11-05. Applicant: Beijing Sinovation Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: 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
Applicant: Beijing Sinovation Medical Technology Co., Ltd.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2025-02-10
Decision date: 2025-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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