# OXC: Mesh, Surgical, Absorbable, Staple Line Reinforcement

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 9
- 510(k) review time 2021–2025: median 127 days (middle half 111–129)
- 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)
- 2013: 2
- 2015: 1
- 2018: 1
- 2019: 1
- 2022: 2
- 2023: 1
- 2026: 1

## Most-cited predicates
- K130997: Neoveil (2013), cited by 2
- K131658: Gore Seamguard Reinforcement (2013), cited by 1
- K181940: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (2018), cited by 1
- K221343: ECHELON ENDOPATH Staple Line Reinforcement (2022), cited by 1
- K190937: Echelon Endopath Staple Line Reinforcement (2019), cited by 1

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