QAU
- Product code
- QAU
- Device name
- Hemostatic Device For Endoscopic Gastrointestinal Use
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4456
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 12
FDA classification 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.
510(k) clearances, last 3 years (6)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261503 | 2026-08-03 | 3-D Matrix, Inc. | PuraStat GI | |
| K253302 | 2026-06-02 | Wilson-Cook Medical, Inc. | Hemospray Endoscopic Hemostat (HEMO-[X]) | FDA |
| K253924 | 2026-01-07 | 3-D Matrix Europe SAS | PuraStat | |
| K240994 | 2024-11-27 | Nextbiomedical Co., Ltd. | Nexpowder | |
| K242250 | 2024-10-22 | 3-D Matrix Europe SAS | PuraStat | |
| K234131 | 2024-07-26 | Hemostasis, LLC | Resolv Endoscopic Hemostat System | FDA |
Official FDA classification page: QAU
Classification and pathway per current FDA publications. Data from openFDA (CC0).