# ORQ: Mesh, Surgical, Deployer

- Device class: 2; regulation: 21 CFR 878.3300; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 54 days (middle half 54–54)
- 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: 2
- 2012: 2
- 2013: 1
- 2025: 1

## Most-cited predicates
- K101218: Patchassist (2010), cited by 4
- K103269: Patchassist Large (2010), cited by 3
- K121139: Accumesh Deployment System (2012), cited by 1
- K123066: Accumesh Deployment System (2012), cited by 1

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