Device Dossier

Irrigation/aspiration system tubing set

Device Dossier for Irrigation/aspiration system tubing set (Irrigation/aspiration system tubing set, Class IIa, sponsor DePuy Synthes). ARTG record,…

Intended purpose

A collection of sterile, flexible, double-bore tubing, and associated items (typically includes clamps, filters, spikes, and connectors), used as twin conduits in an irrigation/aspiration system to deliver irrigation solution to a surgical field through one bore and provide aspiration (suction) through the other during a surgical procedure (e.g., tissue/bone morcellation). The tubing is made of synthetic material and is of a fixed diameter that may be specific to the requirements of the clinical application for which it is intended. This is a single use device.

TGA Public Summary