ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)

The ETHICON 4000 45mm Staplers and ETHICON 3D 45mm Reloads are sterile, single-use surgical instruments that cut and staple tissue simultaneously. They deliver a combination of 3D staples in outer rows and traditional 2D B-shaped staples in inner rows, and are intended for transection, resection, and anastomosis creation in open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures, including liver, pancreas, kidney, and spleen applications.

The subject device has a 45mm staple line length and 42mm cut line length with three shaft configurations (Compact, Standard, Long). A key technological difference is the two-position anvil tip mechanism that toggles between straight and curved configurations, whereas the predicate's 60mm device only allows straight configuration. Both devices share identical staple row patterns (3D outer rows, 2D inner rows), sterilization methods (EO for stapler, gamma for reload), shelf life (3 years), and biocompatibility standards.

ISO 10993-1 biocompatibility standard is cited for materials assessment.

The subject device is substantially equivalent because it performs the same intended use as the predicate device with demonstrated comparable safety and effectiveness through nonclinical testing including vessel sealing, formed staple height, staple form quality, and staple line integrity in solid organs. Performance testing demonstrates functionally equivalent performance to the predicate despite differences in staple line length and the addition of the two-position anvil mechanism.