510(k) Report

Devices descending from K163454

8 later devices reach ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC20225—
+1K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…Ethicon Endo-Surgery, LLC202011
+2K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd.20260—
+2K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20240—
+2K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Ethicon Endo-Surgery, LLC20243—
+3K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+3K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20251—
+4K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…Ethicon Endo-Surgery, LLC20250—