K250420 is an FDA 510(k) clearance for the Helios Dura Regeneration Matrix. This device is classified as a Dura Substitute (Class II - Special Controls, product code GXQ).
Submitted by Helios Biomedical, Inc. (Weston, US). The FDA issued a Cleared decision on May 14, 2025, 90 days after receiving the submission on February 13, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5910.
| 510(k) Number | K250420 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 13, 2025 |
| Decision Date | May 14, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXQ - Dura Substitute |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5910 |