# QSW: Endoscopic Traction Device

- Device class: 2; regulation: 21 CFR 876.4410; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 60 days (middle half 60–60)
- 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)
- 2022: 2

## Most-cited predicates
- DEN220006: ProdiGI (2022), cited by 1

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