Device Dossier

Disposable self-retaining retraction system hook

Device Dossier for Disposable self-retaining retraction system hook (Disposable self-retaining retraction system hook, Class IIa, sponsor Emergo). ARTG…

Intended purpose

A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to a stabilizing device (e.g., mounting frame, arm, table), and as such does not include a handle. It may be in the form of a retracting hook and is available in a variety of lengths and sizes. This is a single-use device intended to be used in a sterile condition.

TGA Public Summary