Device Dossier

Surgical procedure kit, laparoscopic, single-use, non-medicated

Device Dossier for Surgical procedure kit, laparoscopic, single-use, non-medicated (Surgical procedure kit, laparoscopic, single-use, non-medicated,…

Intended purpose

ArtiSential Gastric Bypass and Gastrectomy kit is intended for single use in minimally invasive laparoscopic surgical applications. The fully articulated instrument designed to grasp a suture needle when pushing/ pulling the needle and attached suture through tissue during suturing; implanting, explanting, repositioning mesh or other prosthesis to tissues. The sutures are intended for use in soft tissue to provide wound, tissue, mesh or other prosthesis support, but not for use in cardiovascular or neurological surgery. The wound closure device with a surgical needle intended for single use for soft tissue approximation.

TGA Public Summary