Device Dossier

Endoscopic gas distention system

Device Dossier for Endoscopic gas distention system (Endoscopic gas distention system, Class IIa, sponsor PlainSolution). ARTG record, intended purpose,…

Intended purpose

This is an AC-powered active device used to distend (expand by pressure) the colon or the gastrointestinal (GI) tract by filling the cavity with pressure-limited carbon dioxide (CO2) gas during an endoscopic procedure which may also apply to radiography. Electronics assist in monitoring the pressure and maintaining the gas-filled space by compensating for gas leakage. It is also commonly known as an insufflator.

TGA Public Summary