# QAU: Hemostatic Device For Endoscopic Gastrointestinal Use

- Device class: 2; regulation: 21 CFR 878.4456; FDA's rule: 510(k) required
- FDA decisions: 12
- 510(k) review time 2021–2025: median 211 days (middle half 179–458)
- Recalls: 3 (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)
- 2018: 1
- 2020: 1
- 2021: 2
- 2022: 1
- 2023: 1
- 2024: 3
- 2026: 3

## Most-cited predicates
- DEN170015: Hemospray Endoscopic Hemostat (2018), cited by 5
- K242250: PuraStat (2024), cited by 2
- K222481: PuraStat (2023), cited by 1
- K200972: Hemospray Endoscopic Hemostat (2020), cited by 1
- K190677: EndoClot (2021), cited by 1
- K253924: PuraStat (2026), cited by 1
- K210098: PuraStat-GI (2021), cited by 1

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