510(k) Report

Devices descending from K213633

5 later devices reach ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20240—
+1K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Ethicon Endo-Surgery, LLC20243—
+2K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+2K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20251—
+3K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…Ethicon Endo-Surgery, LLC20250—