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Hemostatic Device For Endoscopic Gastrointestinal Use

FDA product code QAU · 11 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4456
Review panel
SU
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2020-06-10 – 2026-08-03

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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