Device Dossier

Suture/needle passer, single-use

Device Dossier for Suture/needle passer, single-use (Suture/needle passer, single-use, Class IIb, sponsor ConMed Linvatec). ARTG record, intended…

Intended purpose

A sterile, single-use, manually-operated device intended to be used via percutaneous or endoscopic access to facilitate soft tissue repairs, including meniscal tears. The device comprises a handheld disposable device with a needle/suture assembly, that leaves behind a suture/implant construct.

TGA Public Summary