DEN240066 is an FDA 510(k) submission for the COAPTIUM Connect with TISSIUM LIGHT. This device is classified as a In Situ Polymerizing Peripheral Nerve Repair Device (Class II - Special Controls, product code SFD).
Submitted by Tissium SA (Paris, FR). The FDA issued a Not Cleared (DENG) decision on June 17, 2025.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5270. An In Situ Polymerizing Peripheral Nerve Repair Device Is Intended For The Sutureless Repair Of Peripheral Nerve Injuries..
| 510(k) Number | DEN240066 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 21, 2024 |
| Decision Date | June 17, 2025 |
| Days to Decision | 208 days |
| Submission Type | Direct |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | SFD - In Situ Polymerizing Peripheral Nerve Repair Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5270 |
| Definition | An In Situ Polymerizing Peripheral Nerve Repair Device Is Intended For The Sutureless Repair Of Peripheral Nerve Injuries. |