Device Dossier
Flexible video ureterorenoscope, single-use
Device Dossier for Flexible video ureterorenoscope, single-use (Flexible video ureterorenoscope, single-use, Class IIa, sponsor Alvexa Medical). ARTG…
- GMDN category: Flexible video ureterorenoscope, single-use
Intended purpose
The Single-Use Flexible Ureteroscope is designed to be used with the Digital Video Processor intended for the visual examination and treatment of the ureter and kidney. 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.