# SFD: In Situ Polymerizing Peripheral Nerve Repair Device

- Device class: 2; regulation: 21 CFR 882.5270; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 75 days (middle half 75–75)
- Recalls: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2025: 2

## Most-cited predicates
- DEN240066: COAPTIUM Connect with TISSIUM LIGHT (2025), cited by 1

Source page: https://510kreport.com/product-code/SFD
Data by year (CSV): https://510kreport.com/product-code/SFD.csv