510(k) Report

Devices descending from K112056

25 later devices reach Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Ethicon Endo-Surgery, LLC201419Class I
+1K131663Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC201320—
+1K121600Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC201223—
+2K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC20225—
+2K210278Titan SGSStandard Bariatrics20210—
+2K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…Ethicon Endo-Surgery, LLC202011
+2K183435Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackEthicon Endo-Surgery, LLC20193—
+2K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical201863
+2K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…Ethicon Endo-Surgery, LLC201781
+2K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC20169Class I
+2K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc.20144Class I
+3K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd.20260—
+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—
+3K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20240—
+3K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Ethicon Endo-Surgery, LLC20243—
+3K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm…Intuitive Surgical, Inc.20231Class I
+3K191070Signia Small Diameter ReloadsCovidien201927
+3K183224SureForm 45, SureForm 45 ReloadsIntuitive Surgical201951
+4K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…Ethicon Endo-Surgery, LLC20250—
+4K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.20250—
+4K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc.20240Class I
+4K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+4K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc.201941
+5K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc.20212Class I