# OXE: Mesh, Surgical, Collagen, Staple Line Reinforcement

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 4
- 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: 1
- 2003: 1
- 2016: 1
- 2017: 1

## Most-cited predicates
- K030879: Veritas Collagen Matrix (2003), cited by 4
- K022044: Surgisis Staple Line Reinforcement (2002), cited by 2
- K170945: Biodesign Staple Line Reinforcement (2017), cited by 1

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