# OXF: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 150 days (middle half 78–229)
- 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: 1
- 2017: 2
- 2018: 1
- 2022: 1
- 2024: 1
- 2025: 2

## Most-cited predicates
- K163217: GORE BIO-A Tissue Reinforcement (2017), cited by 3
- K123128: Seri Surgical Scaffold (2013), cited by 2
- K232602: 3DMatrix Surgical Mesh (2024), cited by 1
- K173333: GORE ENFORM Biomaterial (2018), cited by 1

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