Device Dossier

Suture/needle passer, single-use

Device Dossier for Suture/needle passer, single-use (Suture/needle passer, single-use, Class IIa, sponsor Zimmer Biomet). ARTG record, intended purpose,…

Intended purpose

A sterile, hand-held, manual surgical instrument designed for passing (driving) sutures and suture needles through tissue to facilitate suturing. A passer, also known as a needle driver, is a long, thin, rod-like device that may be flexible or rigid in design and have hooks, catches, clasps, or forceps-like jaws at the distal end that grip/hold the material being passed through the tissue. The distal end will typically terminate as a button, rounded, or acorn tip, while the proximal end will have a handle or lever that is operated by the user. This is a single-use device.

TGA Public Summary