Device Dossier
Ureterorendoscope, rigid
Device Dossier for Ureterorendoscope, rigid (Ureterorendoscope, rigid, Class IIa, sponsor Actis Medical). ARTG record, intended purpose, GMDN category —…
- GMDN category: Ureterorendoscope, rigid
Intended purpose
An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user through relayed lens optics or a fibre-optic bundle. This device is typically used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This video scope is intended to be used with endotherapy accessories, and other ancillary equipment (i.e Video processor and laser fibre) for treatment of Urolithiasis. This is a reusable device.