DeviceClearance

Product code QAU— General, Plastic Surgery

PuraStat

Classification name
Hemostatic Device For Endoscopic Gastrointestinal Use
Device class
Class 2
Regulation
21 CFR 878.4456
Advisory panel
General, Plastic Surgery
Total cleared
12
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QAU under 21 CFR 878.4456, via openFDA

Market context for product code QAU

FDA has cleared 12 devices under product code QAU between 2018 and 2026, filed by 6 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAU

Adverse events under product code QAU

product code QAU
Death
6
Injury
135
Malfunction
621
Total
762

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code QAU

Data sourced from openFDA. This site is unofficial and independent of the FDA.