Device Dossier

Endotherapy dilator, single use

Device Dossier for Endotherapy dilator, single use (Endotherapy dilator, single use, Class IIa, sponsor William A Cook). ARTG record, intended purpose,…

Intended purpose

Flexor Ureteral Access Sheath: The dilator and sheath ensemble is used to establish a conduit during endoscopic urological procedures by providing lumen patency to facilitate the passage of endoscopes and other instruments into the urinary tract. The thirteen (13) cm length is intended for use in pediatric patients two (2) years of age and over. Flexor Parallel Rapid Release Ureteral Access Sheath: The dilator and sheath ensemble is used to establish a conduit during endoscopic urological procedures by providing lumen patency to facilitating the passage of endoscopes and other instruments into the urinary tract. Peel Away Introducer: The dilator and sheath ensemble is used to establish a conduit during endoscopic or percutaneous urological procedures (e.g. nephrostomy, cystoscopy, ureteroscopy, etc.) by facilitating the passage of endoscopes and other instruments into the urinary tract.

TGA Public Summary