DEN240066
- 510(k) number
- DEN240066
- Device name
- COAPTIUM Connect with TISSIUM LIGHT
- Applicant
- Tissium SA FR
- Product code
- SFD — In Situ Polymerizing Peripheral Nerve Repair Device
- Decision date
- 2025-06-17
- Date received
- 2024-11-21
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Neurology
Official FDA record: DEN240066
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.