In Situ Polymerizing Peripheral Nerve Repair Device
Regulation 882.5270
0510(k)s in 12 months (2 all time)
8recalls in 12 months (8 all time)
0recalls that name a 510(k)
Top companies in SFD
| Company | 510(k)s | Recalls |
|---|---|---|
| Tissium SA | 2 | 8 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 8, 2025 | K251957 | Coaptium Connect with Tissium Light Tissium SA, FR | SFD |
| Jun 17, 2025 | DEN240066 | COAPTIUM Connect with TISSIUM LIGHT Tissium SA, FR | SFD |
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