Device Dossier

Gastrointestinal endoscopic clip, long-term

Device Dossier for Gastrointestinal endoscopic clip, long-term (Gastrointestinal endoscopic clip, long-term, Class IIb, sponsor Centaurus Healthcare).…

Intended purpose

The instrument is designed to be used with endoscope for clipping of the soft tissue in gastrointestinal (GI) tract for the purpose of endoscopic marking; haemostasis for mucosal/sub-mucosal defects < 3 cm; bleeding ulcers; Wound occlusion after Polyps resection; diverticula in the colon; and as a supplementary method of closure of GI tract luminal perforation <20mm, that can be treated conservatively.

TGA Public Summary