SEEG-Tx® System (STX-SYS-001)— 510(k) K260337

Name: FDA 510(k) clearance K260337
Creator: U.S. Food and Drug Administration
Published: 2026-10-29

Substantially Equivalent

Dixi Medical

FDA 510(k) clearance K260337 for SEEG-Tx® System (STX-SYS-001), Substantially Equivalent on 2026-10-29. Applicant: Dixi Medical. Device class: 2.

Clearance details

Applicant: Dixi Medical
Product code: Product code GXD
Device class: Class 2
Regulation: 21 CFR 882.4400
Advisory panel: Neurology
Date received: 2026-02-02
Decision date: 2026-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marchaux-Chaudefontaine, FR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GXD

product code GXD

Injury: 228
Total: 228

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.