Device Dossier

Flexible video ureterorenoscope, single-use

Device Dossier for Flexible video ureterorenoscope, single-use (Flexible video ureterorenoscope, single-use, Class IIa, sponsor Medilaze Surgical). ARTG…

Intended purpose

The device is introduced within the urinary tract for endoscopic examination or treatment. The device can be used to examine the urinary tract and interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. This is to be performed by skilled physicians trained in clinical endoscopic techniques and procedures. Images are transmitted to the user through a Medical Image Processor for clinical image processing. This is a single-use device.

TGA Public Summary