510(k) Report

Devices descending from K951546

111 later devices reach Endopath and Proximate Linear Cutters and Staplers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090821Chex Single Use Curved Intraluminal Circular Stapler, Model CS 21, CS 25, CS 28, CS 32…Frankenman International Limited200921—
+1K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc.199888—
+2K120179Reach Surgical StaplersReach Surgical, Inc.201217—
+2K101378Frankenman Surgical StaplersSuzhou Frankenman Medical Equipment Co., Ltd.20101—
+2K100386Disposable Circular Stapler, Models Why-25, Why-29. Why 32Changzhou Waston Medical Appliance Co., Ltd.20100—
+2K070859Reprocessed Ethicon Ets Endoscopic Linear CuttersSterilmed, Inc.20070—
+2K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.20028717
+3K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler…Ethicon Endo-Surgery, LLC20250—
+3K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™…Ethicon Endo-Surgery202301
+3K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+3K192566Reach and CQ'ENCE Circular StaplersReach Surgical, Inc.20190—
+3K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single UseEzisurg (Suzhou) Medical Co., Ltd.20190—
+3K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular…Ezisurg Medical Co., Ltd.20190—
+3K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+3K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+3K161905Disposable Circular Stapler for Hemorrhoids, Disposable Circular Stapler, Disposable…Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd20160—
+3K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…Cardica, Inc.20161—
+3K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife…Ethicon Endo-Surgery, LLC20150—
+3K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc.20144Class I
+3K141367LS Series Linear Stapler and Reloads, CLC Series Curved Linear Cutter and Reloads, LC…Touchstone International Medical Science Co., Ltd.20147—
+3K133499Suzhou Beinuo Surgical Staplers - Circular Staplers for Single Use, Hemorrhoidal…Suzhou Beinuo Medical Equipment Co., Ltd.20140—
+3K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+3K130738Endoscopic Linear Cutting Staplers with Single Use Loading UnitsNanjing Maidixin Medical Device Co., Ltd.20130—
+3K131511Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear…Changzhou Sinolinks Medical Innovation Co., Ltd.201314—
+3K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+3K111111Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic…Ethicon Endo-Surgery, LLC201153
+3K110049Reusable Linear Stapler HandleEthicon Endo-Surgery, LLC20110—
+3K092577Ethicon Endo-Surgery Linear Cutter 55MM (NTLC55),Selectable Cartridge 55 / 75MM…Ethicon Endo-Surgery, LLC20090—
+3K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc.20057—
+3K033578Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc.20050—
+3K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20046—
+3K033324Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20047—
+3K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc.200346—
+4K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use…Ezisurg Medical Co., Ltd.20260—
+4K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+4K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+4K191070Signia Small Diameter ReloadsCovidien201927
+4K173443AEON Endoscopic StaplerLexington Medical, Inc.20185—
+4K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+4K171589AEON Endoscopic StaplerLexington Medical, Inc.20170—
+4K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+4K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+4K141097CSC Series Intraluminal Stapler for Single UseTouchstone International Medical Science Co., Ltd.20140—
+4K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+4K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+4K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200751
+4K053524C-Port Distal Anastomosis SystemCardica, Inc.200661
+4K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20052—
+4K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd.20045—
+4K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.200445—
+5K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20251—
+5K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+5K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+5K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+5K182380AEON Endoscopic StaplerLexington Medical, Inc.20184—
+5K093661ColonringNiti Surgical Solutions, Ltd.20110—
+5K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+5K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200911
+5K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc.20070—
+5K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.200711
+5K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20061—
+5K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc.2004251
+6K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20260—
+6K201882AEON Endoscopic StaplerLexington Medical, Inc.20203—
+6K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+6K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+6K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+6K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+6K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+6K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.201001
+6K073123Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150Cardica, Inc.200701
+6K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.2007211
+6K052415Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc.2005151
+7K222210AEON Endoscopic StaplerLexington Medical, Inc.20232—
+7K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+7K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+7K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+7K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+7K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc.200901
+7K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc.200801
+7K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc.200801
+7K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.2007111
+7K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+7K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc.200713—
+7K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc.20060—
+8K251482AEON™ Endoscopic Powered StaplerLexington Medical, Inc.20250—
+8K234039AEON Endoscopic Powered Stapler (Short/AEPH060); AEON Endoscopic Powered Stapler…Lexington Medical, Inc.20240—
+8K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+8K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+8K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+8K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+8K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+8K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109—
+9K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+9K180010AtriClip FLEX-VAtriCure, Inc.20188—
+9K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+10K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+10K160176Signia StaplerCovidien2016514
+10K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+10K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—