In Situ Polymerizing Peripheral Nerve Repair Device
FDA product code SFD · Class II (moderate risk) · 21 CFR 882.5270 · Neurology
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
1510(k) clearances
0PMA approvals
8recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251957 | Coaptium Connect with Tissium LightSFD · Special | Tissium SA | 09/08/2025SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2908-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2907-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2906-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2905-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2904-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2903-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2902-2026 Class II | Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |
| Z-2901-2026 Class II | Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number:…Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled… | Tissium SA | 06/15/2026Open, Classified |