Device Dossier

Endoscopic Helical Tacking System - Gastrointestinal endoscopic clip, long-term

Device Dossier for Endoscopic Helical Tacking System - Gastrointestinal endoscopic clip, long-term (Gastrointestinal endoscopic clip, long-term, Class…

Intended purpose

This system is intended for approximation of soft tissue in minimally invasive gastroenterology procedures (e.g. closure and healing of ESD/EMR sites, and closing of fistula, perforation or leaks). It is not intended for hemostasis of acute bleeding ulcers.

TGA Public Summary