Device Dossier

Flexible video bronchoscope, single-use

Device Dossier for Flexible video bronchoscope, single-use (Flexible video bronchoscope, single-use, Class IIa, sponsor Koala Medical). ARTG record,…

Intended purpose

The product is a single-use sterile flexible endoscope for endoscopic surgery and examination in the anatomy of nasal cavity and upper respiratory tract. The endoscope is used to provide images through an endoscopy video processor manufactured by HugeMed. The single-use flexible bronchoscope is connected to an endoscopy video processor manufactured by HugeMed, and used in conjunction with other endoscopic accessories for the examination and treatment of trachea and bronchus in adults.

TGA Public Summary