# OQL: Mesh, Surgical, Deployment Balloon

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

## Most-cited predicates
- K092726: Mesh GPS - Large, Small, SM, SM Small (2010), cited by 1

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