Device Dossier

Flexible video ureteroscope, single-use

Device Dossier for Flexible video ureteroscope, single-use (Flexible video ureteroscope, single-use, Class IIa, sponsor PlainSolution). ARTG record,…

Intended purpose

It is an endoscope intended for the visual examination and treatment of the ureter. It is inserted through the external urethral orifice and bladder during ureteroscopy. This device is normally used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a single-use device.

TGA Public Summary