ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)

The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are sterile, single-use surgical instruments that simultaneously cut and staple tissue for transection, resection, and creation of anastomoses in general, urologic, thoracic, and pediatric procedures. This submission expands the indications to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The subject device features six staggered rows of staples with 3D staple form in rows 1, 2, 5, and 6, while maintaining 2D B-formed staples in rows 3 and 4 nearest the knife. It has a 60 mm staple line length, EO sterilization for staplers and gamma irradiation for reloads, 3-year shelf life, biocompatibility per ISO 10993-1, and is available in three shaft lengths (Compact, Standard, Long). The subject device is technologically identical to the reference device (K241630) with only the indications expanded to include solid organs.

ISO 10993-1 for biocompatibility of materials.

The device is substantially equivalent because it is technologically identical to the predicate device (ECHELON™ 3000, K241629) and reference device (ETHICON™ 4000, K241630) in all design characteristics. Performance testing including bench tests (vessel sealing, staple height, staple form quality, staple line integrity) and preclinical animal testing (hemostasis in liver, spleen, pancreas using porcine models, plus isolated vessels and tissues) demonstrated safety and effectiveness for the expanded indications to solid organs. Since the device's fundamental design and mechanism remain unchanged, and testing confirms it performs as intended in the newly claimed organ tissues, no new safety or effectiveness questions are raised.