# OXD: Mesh, Surgical, Non-Absorbable, Staple Line Reinforcement

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 3
- 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)
- 1996: 1
- 2000: 1
- 2001: 1

## Most-cited predicates
- K001789: Seamguard Staple Line Reinforcement Material (2000), cited by 4
- K010936: Modification to Seamguard Staple Line Reinforcement Material (2001), cited by 2
- K955364: Seamguard Staple Line Reinforcement Material (1996), cited by 1

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