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,…
- GMDN category: Endoscopic gas distention system
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.