ClearanceBrief
510(k) K250835 ยท GDW Staple, Implantable

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)

ApplicantEthicon Endo-Surgery, LLC, Guaynabo PR, US
DecisionSubstantially Equivalent, May 14, 2025
ReceivedMar 20, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250835

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.