Data / Medical devices / Hemostatic Device For Endoscopic Gastrointestinal Use
Hemostatic Device For Endoscopic Gastrointestinal Use (QAU): 8 FDA-registered makers in 6 countries
8 establishments in 6 countries are registered with the FDA to make Hemostatic Device For Endoscopic Gastrointestinal Use (product code QAU, Class 2, 21 CFR 878.4456). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on August 3, 2026, and lists 6 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QAU
- Device class
- 2
- Regulation
- 878.4456
- Medical specialty
- General, Plastic Surgery
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| France | 1 |
| South Korea | 1 |
| China | 1 |
| Japan | 1 |
| Germany | 1 |
Makers of Hemostatic Device For Endoscopic Gastrointestinal Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| 3-D Matrix Europe SAS | Caluire et Cuire Rhone, France | Complaint file establishment, Manufacturer, Specification developer | 3 | August 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| 3-D Matrix, Inc. | Newton, MA, United States | Complaint file establishment, Manufacturer | 3 | August 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nextbiomedical Co., Ltd | Incheon, South Korea | Complaint file establishment, Manufacturer | 2 | November 27, 2024 | 0 | 0 | 0 | api.fda.gov |
| Endoclot Plus Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | January 29, 2021 | 0 | 0 | 0 | api.fda.gov |
| Hemostasis, LLC | Saint Paul, MN, United States | Manufacturer | 1 | July 26, 2024 | 0 | 0 | 0 | api.fda.gov |
| Wilson-Cook Medical Inc. | Winston Salem, NC, United States | Complaint file establishment, Manufacturer | 1 | June 10, 2020 | 0 | 6 | 0 | api.fda.gov |
| Fuso Pharmaceutical | Joto-ku Osaka, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pharmpur GMBH | Konigsbrunn, Bavaria, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.