Hemostatic Device for Endoscopic Gastrointestinal Use

What Is This Device?

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.

What Is FDA Product Code QAU?

Hemostatic Device For Endoscopic Gastrointestinal Use is FDA product code QAU, Class 2, 21 CFR 878.4456.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 686 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 8 recalls under this product code since 2019. None was by a company in China. The root causes the FDA records most often are Device Design (2), Nonconforming Material/Component (2) and Labeling design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.