# NWJ: Suture, Recombinant Technology

- Device class: 2; regulation: 21 CFR 878.4494; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 28 days (middle half 28–28)
- Recalls: 0 (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)
- 2007: 2
- 2008: 2
- 2010: 1
- 2012: 1
- 2013: 2
- 2021: 1

## Most-cited predicates
- K082178: Tephaflex Absorbable Suture (2008), cited by 4
- DEN060003: Tephaflex Absorbable Suture (2007), cited by 4
- K081099: Tephaflex Absorbable Suture (2008), cited by 2
- K122487: Biofiber Syture (2012), cited by 2
- K130422: Phantom Fiber Biofiber Suture (2013), cited by 1

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