K251191
- 510(k) number
- K251191
- Device name
- Collagen Dura Regeneration Membrane - Repair
- Applicant
- Collagen Matrix, Inc. NJ · US
- Product code
- GXQ — Dura Substitute
- Decision date
- 2025-11-18
- Date received
- 2025-04-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K251191.pdf
Official FDA record: K251191
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.