510(k) DEN240066
DEN240066 is an FDA 510(k) premarket notification submitted by Tissium SA for the device "COAPTIUM Connect with TISSIUM LIGHT". The FDA issued a decision of De Novo Granted on June 17, 2025. The device falls under product code SFD (In Situ Polymerizing Peripheral Nerve Repair Device), a Class II device regulated under 21 CFR 882.5270. Tissium SA has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- June 17, 2025
- Date Received
- November 21, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- In Situ Polymerizing Peripheral Nerve Repair Device
- Device Class
- Class II
- Regulation Number
- 882.5270
- Review Panel
- NE
- Submission Type
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.