# OWT: Mesh, Surgical, Absorbable, Abdominal Hernia

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 13
- 510(k) review time 2021–2025: median 111 days (middle half 101–122)
- 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)
- 2010: 1
- 2012: 1
- 2015: 1
- 2017: 1
- 2018: 1
- 2019: 2
- 2020: 1
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K033671: Gore Bioabsorbable Mesh (2003), cited by 7
- K143380: Phasix ST Mesh (2015), cited by 2
- K101287: Tephaflex Composite Mesh (2010), cited by 1
- K191749: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh (2020), cited by 1
- K173143: Phasix ST Mesh (2018), cited by 1
- K163005: TIGR Matrix Surgical Mesh (2017), cited by 1
- K190185: Phasix ST Mesh with Open Positioning System (2019), cited by 1

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