Device typeHysteroscopic irrigation/insufflation system: A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.
FDA categoryHYSTEROSCOPE (AND ACCESSORIES), Insufflator, hysteroscopic
Device ID15420045516212
Catalog numberFLT-200
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information