Hemostatic Device For Endoscopic Gastrointestinal Use
QAU · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4456
Classification
FDA Product Code
QAU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4456
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.