Device type
Hemostatic Device For Endoscopic Gastrointestinal Use
Product code QAU · Class II · 21 CFR 878.4456 · General, Plastic Surgery
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.
Recent 510(k)s
No 510(k) clearances in the archive for QAU.
Recent recalls
Sep 23, 2026
Z-3177-2026
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Ver…
Wilson-Cook Medical Inc.
- QAU
- Class II
- Ongoing