Device Dossier

Cystoscope, flexible, video

Device Dossier for Cystoscope, flexible, video (Cystoscope, flexible, video, Class IIa, sponsor Actis Medical). ARTG record, intended purpose, GMDN…

Intended purpose

The Video Cystoscope with a flexible inserted portion is intended for examination and treatment of bladder superficial abnormalities through a transurethral route. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a reusable device.

TGA Public Summary