K251957 is an FDA 510(k) clearance 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 Cleared decision on September 8, 2025, 75 days after receiving the submission on June 25, 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 | K251957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 2025 |
| Decision Date | September 08, 2025 |
| Days to Decision | 75 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| 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. |