SFD
- Product code
- SFD
- Device name
- In Situ Polymerizing Peripheral Nerve Repair Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 882.5270
- Medical specialty
- Neurology
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
FDA classification definition
An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251957 | 2025-09-08 | Tissium SA | Coaptium Connect with Tissium Light | |
| DEN240066 | 2025-06-17 | Tissium SA | COAPTIUM Connect with TISSIUM LIGHT | — |
Official FDA classification page: SFD
Classification and pathway per current FDA publications. Data from openFDA (CC0).