FDA product code QAU

Hemostatic Device For Endoscopic Gastrointestinal Use

General, Plastic Surgery·Class 2·21 CFR 878.4456·Implantable
US regulatory classifications
US Product Code (FDA)
QAU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4456
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Hemostatic Device For Endoscopic Gastrointestinal Use is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.