GXQ
- Product code
- GXQ
- Device name
- Dura Substitute
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5910
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 43 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251191 | 2025-11-18 | Collagen Matrix, Inc. | Collagen Dura Regeneration Membrane - Repair | FDA |
| K250420 | 2025-05-14 | Helios Biomedical, Inc. | Helios Dura Regeneration Matrix |
Official FDA classification page: GXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).