Device Dossier

Flexible video bronchoscope, single-use

Device Dossier for Flexible video bronchoscope, single-use (Flexible video bronchoscope, single-use, Class IIa, sponsor C R Kennedy & Co). ARTG record,…

Intended purpose

A sterile endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

TGA Public Summary