Device Dossier

Endotherapy overtube, single-use

Device Dossier for Endotherapy overtube, single-use (Endotherapy overtube, single-use, Class IIa, sponsor Fujifilm). ARTG record, intended purpose, GMDN…

Intended purpose

The over tube is designed to ensure complete positioning of the endoscope without risk of injury, by inflating the balloon on the overtube to grip the small intestine, while the tip of the scope can be smoothly inserted to reach the area of diagnosis.

TGA Public Summary