510(k) Report

Devices descending from K111111

5 later devices reach Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc.20144Class I
+2K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd.20260—
+2K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+2K191070Signia Small Diameter ReloadsCovidien201927
+3K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211