Helios Dura Regeneration Matrix— 510(k) K250420

Substantially Equivalent

Helios Biomedical, Inc.

FDA 510(k) clearance K250420 for Helios Dura Regeneration Matrix, Substantially Equivalent on 2025-05-14. Applicant: Helios Biomedical, Inc..

Clearance details

Applicant: Helios Biomedical, Inc.
Product code: Code GXQ
Advisory panel: Neurology
Date received: 2025-02-13
Decision date: 2025-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weston, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GXQ

product code GXQ

Death: 11
Injury: 446
Other: 1
Total: 458

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.