FDA product code QAU: Hemostatic Device For Endoscopic Gastrointestinal Use
QAU is the FDA product code for hemostatic device for endoscopic gastrointestinal use. It is a Class II device, regulated under 21 CFR 878.4456 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under QAU, 8 in the last five years, from 6 different applicants. The average 510(k) review took 246 days (median 195); 148 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 8 recalls for QAU devices, 5 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Hemostatic Device For Endoscopic Gastrointestinal Use |
| Device class | Class II |
| Regulation | 21 CFR 878.4456 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for QAU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 58 |
| 2021 | 2 | 424 |
| 2022 | 1 | 717 |
| 2023 | 1 | 195 |
| 2024 | 3 | 175 |
| 2026 | 3 | 122 |
Compare with all 510(k) review times · Search every QAU clearance
Top QAU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| 3-D Matrix, Inc. | 3 | 2026-08-03 |
| Wilson-Cook Medical, Inc. | 2 | 2026-06-02 |
| 3-D Matrix Europe SAS | 2 | 2026-01-07 |
| Nextbiomedical Co., Ltd. | 2 | 2024-11-27 |
| Hemostasis, LLC | 1 | 2024-07-26 |
1 more applicants have QAU clearances. See the full list in Caduvo.
Most recent QAU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261503 | 3-D Matrix, Inc. | PuraStat GI | 2026-08-03 | 89 |
| K253302 | Wilson-Cook Medical, Inc. | Hemospray Endoscopic Hemostat (HEMO-[X]) | 2026-06-02 | 246 |
| K253924 | 3-D Matrix Europe SAS | PuraStat | 2026-01-07 | 30 |
| K240994 | Nextbiomedical Co., Ltd. | Nexpowder | 2024-11-27 | 230 |
| K242250 | 3-D Matrix Europe SAS | PuraStat | 2024-10-22 | 83 |
Recalls for QAU devices
8 product recalls in 6 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2026-08-20.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2020 | 2 |
| 2023 | 2 |
| 2024 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QAU?
QAU is the FDA product code for hemostatic device for endoscopic gastrointestinal use. It is a Class II device, regulated under 21 CFR 878.4456 and reviewed by the General and Plastic Surgery panel.
What device class is QAU?
Class II, regulation 21 CFR 878.4456. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAU?
Across 11 cleared submissions the average was 246 days from receipt to decision (median 195).
Which companies have the most QAU clearances?
3-D Matrix, Inc. (3); Wilson-Cook Medical, Inc. (2); 3-D Matrix Europe SAS (2); Nextbiomedical Co., Ltd. (2); Hemostasis, LLC (1).
Have QAU devices been recalled?
Yes: 8 product recalls across 6 recall events; the most recent began 2026-08-20.
Next steps
- Run an FDA pathway report with predicate devices for product code QAU
- Run a recall and safety report across every QAU manufacturer
- Watch product code QAU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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