Device Dossier
Endotherapy overtube, single-use
Device Dossier for Endotherapy overtube, single-use (Endotherapy overtube, single-use, Class IIa, sponsor Olympus). ARTG record, intended purpose, GMDN…
- GMDN category: Endotherapy overtube, single-use
Intended purpose
The overtube is designed to ensure complete positioning of the flexible endoscope for endoscopic insertions in the small intestine. By inflating the balloon on the tip of the overtube, it anchors the overtube in the small intestine, allowing the endoscope to be smoothly inserted to reach the area of diagnosis, biopsy and/or treatment of small intestine lesions.