Device Dossier

Unclassified

Device Dossier for Unclassified (Unclassified, Class IIa, sponsor Olympus). ARTG record, intended purpose, GMDN category — compiled by arcimedes.

Intended purpose

Disposable tip and drape are attached to a re-usable handle that is battery powered. By pressing a button on the reusable handle, energy is delivered to the tip which heats up instantly. The heated tip is applied to a Smart piston, causing it to close during incus attachment in ENT surgery. The handle is wrapped with the drape so that it can be reused without extensive cleaning.

TGA Public Summary