Device Dossier

Fluid Management System - Hysteroscopic irrigation/distention system

Device Dossier for Fluid Management System - Hysteroscopic irrigation/distention system (Hysteroscopic irrigation/distention system, Class IIb, sponsor…

Intended purpose

The System is a combined suction and irrigation control unit for use in gynecological interventions. It is intended to provide liquid distension of the uterus during diagnostic and operative hysteroscopy and to monitor the volume differential between the distension fluid flowing into and out of the uterus.

TGA Public Summary