Device Dossier

Flexible video cystoscope, single-use

Device Dossier for Flexible video cystoscope, single-use (Flexible video cystoscope, single-use, Class IIa, sponsor Innovia). ARTG record, intended…

Intended purpose

The device is a single-use, sterile, flexible cystoscope intended for endoscopic visualisation, examination and treatment support in the lower urinary tract. It is intended to be used by trained healthcare professionals in conjunction with a compatible image processor and compatible endoscopic accessories to perform diagnostic and therapeutic procedures in the lower urinary tract.

TGA Public Summary