Hemostatic Device For Endoscopic Gastrointestinal Use
Medical specialty
General, Plastic Surgery
Device class
2
Regulation number
878.4456
Review panel
SU
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.