QAU
12 FDA 510(k) clearances · Product code
211 daysmedian time to decision
686 days90th percentile
12clearances measured
FDA profile
- Official device name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4456
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- Hemostatic device for intraluminal gastrointestinal use. A hemostatic device for intraluminal gastrointestinal use is a prescription device that is endoscopically applied to the upper and/or lower gastrointestinal tract and is intended to produce hemostasis via absorption of fluid or by other physical means.
- Adverse events (MAUDE)
- 2021: 112 · 2022: 135 · 2023: 132 · 2024: 154 · 2025: 126 · 2026: 71
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PuraStat GI (K261503) | 3-D Matrix, Inc. | 2026-08-03 |
| Hemospray Endoscopic Hemostat (HEMO-[X]) (K253302) | Wilson-Cook Medical, Inc. | 2026-06-02 |
| PuraStat (K253924) | 3-D Matrix Europe SAS | 2026-01-07 |
| Nexpowder (K240994) | Nextbiomedical Co., Ltd. | 2024-11-27 |
| PuraStat (K242250) | 3-D Matrix Europe SAS | 2024-10-22 |
| Resolv Endoscopic Hemostat System (K234131) | Hemostasis, LLC | 2024-07-26 |
| PuraStat (K222481) | 3-D Matrix, Inc. | 2023-02-28 |
| Nexpowder (K202929) | Nextbiomedical Co., Ltd. | 2022-09-16 |
| PuraStat-GI (K210098) | 3-D Matrix, Inc. | 2021-06-25 |
| EndoClot (K190677) | Endoclot Plus Co., Ltd. | 2021-01-29 |
| Hemospray Endoscopic Hemostat (K200972) | Wilson-Cook Medical, Inc. | 2020-06-10 |
| Hemospray Endoscopic Hemostat (DEN170015) | Wilson-Cook Medical, Inc. | 2018-05-07 |
Track QAU automatically
Every clearance here is in the API, with alerts when new ones post.