Device Dossier

ETHICON™ 4000 Staplers - Motorized cutting surgical stapler

Device Dossier for ETHICON™ 4000 Staplers - Motorized cutting surgical stapler (Motorized cutting surgical stapler, Class III, sponsor Johnson & Johnson…

Intended purpose

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

Functional description

ETHICON™ 4000 Staplers facilitate delivery of staples while simultaneously cutting the tissue. The instruments are packaged with a primary lithium Battery Pack that must be installed prior to use. The instruments are packaged without a reload and must be loaded prior to use.

TGA Public Summary