Helios Dura Regeneration Matrix— 510(k) K250420
Substantially EquivalentHelios Biomedical, Inc.
FDA 510(k) clearance K250420 for Helios Dura Regeneration Matrix, Substantially Equivalent on 2025-05-14. Applicant: Helios Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Helios Biomedical, Inc.
- Product code
- Code GXQ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5910
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Weston, MA, US
Recent devices under product code GXQ
view allMore clearances from Helios Biomedical, Inc.
view allAdverse events under product code GXQ
product code GXQ- Death
- 11
- Injury
- 446
- Other
- 1
- Total
- 458
Source: openFDA MAUDE database, through . 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.