# NJU: Suture, Nonabsorbable, Nitinol

- Device class: 2; regulation: 21 CFR 878.4495; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 2002: 2

## Most-cited predicates
- K023125: Coalescent U-Clip- and Accessories (2002), cited by 6
- K023372: Non-Bioabsorbable Staple (2002), cited by 1

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