510(k) Report

Devices descending from K081146

50 later devices reach Echelon Endoscopic Linear Cutters (Articulating and Straight) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190331Applied Medical Laparoscopic Linear CutterApplied Medical Resources Corporation20190—
+1K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc.20144Class I
+1K121600Echelon 60 Endoscpic Linear Cutter Reload, WhiteEthicon Endo-Surgery, LLC201223—
+1K120179Reach Surgical StaplersReach Surgical, Inc.201217—
+1K112056Echelon 60 Endoscopic Linear Cutter Reload, Black Model ECR60T, Echelon 45 Endoscopic…Ethicon Endo-Surgery, LLC2011251
+1K110385Echelon Flex 45 / 60 Powered Articulating Endoscopic Linear CutterEthicon Endo-Surgery, Inc.201127—
+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—
+2K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+2K192566Reach and CQ'ENCE Circular StaplersReach Surgical, Inc.20190—
+2K191070Signia Small Diameter ReloadsCovidien201927
+2K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd20160—
+2K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd.20147—
+2K140560Echelon Flex Powered Plus Articulating Endoscopic Linear Cutter, 60MM, Standard, Echelon…Ethicon Endo-Surgery, LLC201419Class I
+2K130738Endoscopic Linear Cutting Staplers with Single Use Loading UnitsNanjing Maidixin Medical Device Co., Ltd.20130—
+2K131663Echelon Endoscopic Linear Cutter Reload, BlackEthicon Endo-Surgery, LLC201320—
+2K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd.201314—
+2K130653Echelon Flex 45 Powered Articulating Endoscopic Linear Cutter; Echelon Flex 60 Powered…Ethicon Endo-Surgery, LLC201323—
+3K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+3K213633ECHELON 3000 45mm Stapler, ECHELON 3000 60mm StaplerEthicon Endo-Surgery, LLC20225—
+3K202709Disposable Powered Endoscopic Linear Cutting Staplers and CartridgesNingbo Verykind Medical Device Co., Ltd.20210—
+3K210278Titan SGSStandard Bariatrics20210—
+3K202665Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm…Ethicon Endo-Surgery, LLC202011
+3K182476Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsFengh Medical Co., Ltd.20191—
+3K183435Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and BlackEthicon Endo-Surgery, LLC20193—
+3K173721SureForm 60 and SureForm 60 ReloadsIntuitive Surgical201863
+3K173443AEON Endoscopic StaplerLexington Medical, Inc.20185—
+3K171589AEON Endoscopic StaplerLexington Medical, Inc.20170—
+3K163454ECHELON FLEX 45mm Powered Plus Articulating Endoscopic Linear Cutters, ECHELON ENDOPATH…Ethicon Endo-Surgery, LLC201781
+3K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+3K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mmEthicon Endo-Surgery, LLC20169Class I
+3K141097CSC Series Intraluminal Stapler for Single UseTouchstone International Medical Science Co., Ltd.20140—
+4K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20251—
+4K241630ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler…Ethicon Endo-Surgery, LLC20240—
+4K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S)…Ethicon Endo-Surgery, LLC20243—
+4K222839EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm…Intuitive Surgical, Inc.20231Class I
+4K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+4K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+4K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsFengh Medical Co., Ltd.20200—
+4K183224SureForm 45, SureForm 45 ReloadsIntuitive Surgical201951
+4K182380AEON Endoscopic StaplerLexington Medical, Inc.20184—
+5K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler…Ethicon Endo-Surgery, LLC20250—
+5K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.20250—
+5K2416388mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsIntuitive Surgical, Inc.20240Class I
+5K201882AEON Endoscopic StaplerLexington Medical, Inc.20203—
+5K190999SureForm 45 Curved Tip, SureForm 45 Gray ReloadIntuitive Surgical, Inc.201941
+6K222210AEON Endoscopic StaplerLexington Medical, Inc.20232—
+6K2119978 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsIntuitive Surgical, Inc.20212Class I
+7K251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.20250—
+7K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…Lexington Medical, Inc.20240—