Device Dossier

Endotherapy needle, single use

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

Intended purpose

Injection Needle is intended to be used for submucosal injection on endoscopic resection of stomach polyps and ≥20mm polyps in colon for adult patients. The submucosal injection is used to create a cushion that lifts the polyp and separates it from the muscularis propria. The size of the polyp should be taken into account when selecting the length and tip for the needle and the specific size is subject to physician's review and the clinical situation.