510(k) Report

Devices descending from K821994

90 later devices reach Disposable Linear Stapler-(LSR) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032973Reprocessed Disposable Cutters, Staplers and AppliersVanguard Medical Concepts, Inc.20030—
+1K020779Proximate and Endopath Linear Cutters and StaplersEthicon Endo-Surgery, Inc.20028717
+1K980023Endopath and Proximate Linear CuttersEthicon Endo-Surgery, Inc.199888—
+2K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler…Ethicon Endo-Surgery, LLC20250—
+2K223760ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELON LINEAR™…Ethicon Endo-Surgery202301
+2K182217Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single UseEzisurg (Suzhou) Medical Co., Ltd.20190—
+2K181657easyLCTM Linear Cutter Staplers and Loading Units fot Single Use; easyCSTM Circular…Ezisurg Medical Co., Ltd.20190—
+2K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+2K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+2K151081MicroCutter XCHANGE 30 Stapler, MicroCutter XCHANGE 30 Blue Cartridge, MicroCutter…Cardica, Inc.20161—
+2K150026Endopath ETS-Flex45 Endoscopic Articulating Linear Cutter, Endopath ETS-Flex45 No-Knife…Ethicon Endo-Surgery, LLC20150—
+2K141952Echelon Flex Powered Vascular Stapler with Advanced Placement Tip, Endopath Echelon…Ethicon Endo-Surgery, Inc.20144Class I
+2K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+2K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+2K111111Endopath Ets 35MM Endoscopic Linear Cutter and Reloads, and Ets-Flex 35MM Endoscopic…Ethicon Endo-Surgery, LLC201153
+2K110049Reusable Linear Stapler HandleEthicon Endo-Surgery, LLC20110—
+2K092577Ethicon Endo-Surgery Linear Cutter 55MM (NTLC55),Selectable Cartridge 55 / 75MM…Ethicon Endo-Surgery, LLC20090—
+2K070859Reprocessed Ethicon Ets Endoscopic Linear CuttersSterilmed, Inc.20070—
+2K040832C-Port Anastomosis System (Deployment System, Clip, Accessories), Model FG-000050Cardica, Inc.20057—
+2K033578Reprocessed Reloadable Cutters, Staplers, and AppliersClearmedical, Inc.20050—
+2K041751Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20046—
+2K033324Compression Anastomosis Clip (Cac)Niti Medical Technologies, Ltd.20047—
+2K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc.200346—
+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—
+3K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+3K191070Signia Small Diameter ReloadsCovidien201927
+3K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+3K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+3K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+3K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+3K063644Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200751
+3K053524C-Port Distal Anastomosis SystemCardica, Inc.200661
+3K050356Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20052—
+3K043115Laparoscopic Compression Anastomosis Clip (Lapcac)Niti Medical Technologies, Ltd.20045—
+3K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.200445—
+4K250541Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20251—
+4K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+4K093661ColonringNiti Surgical Solutions, Ltd.20110—
+4K093679Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove Clip, Gillinov-Cosgrove…AtriCure, Inc.201018—
+4K090872Modification to Cardica C-Port XA Distal Anastomosis SystemCardica, Inc.200911
+4K073304Cardica C-Port X-Change Anastomosis System and Handle and XA X-Change SubassembliesCardica, Inc.20070—
+4K070548C-Port Flexa Distal Anastomosis SystemCardica, Inc.200711
+4K062008Endo Car Compression Anastomosis Ring (Car)Niti Medical Technologies, Ltd.20061—
+4K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc.2004251
+5K253550Self-Forming Magnet (Flexagon Plus OTOLoc)GI Windows, Inc.20260—
+5K163261AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded…AtriCure, Inc.20171—
+5K150996AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20150—
+5K142120Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.20141—
+5K131107Atriclip Gillinov-Cosgrove Laa ClipAtriCure, Inc.20132—
+5K122276Atriclip Laa Exclusion System with Preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201215—
+5K101018Cardica C-Port XA Plus Distal Anastomosis System, Model FG-000100Cardica, Inc.201001
+5K073123Cardica C-Port Flex-a Distal Anastomosis System, Model FG-000150Cardica, Inc.200701
+5K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.2007211
+5K052415Power Linear Cutter Reusable Digital Loading Units with ReloadsPower Medical Interventions, Inc.2005151
+6K172742AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)AtriCure, Inc.20170—
+6K160454AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove ClipAtriCure, Inc.201602
+6K153500AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V ClipAtriCure, Inc.201610—
+6K101797Sonicision Cordless Ultrasonic Dissection Device Model SCD391, SCD396, SCT12, SCG, SCB…Covidien, Formerly Valleylab, A Division of Tyco20115—
+6K091215Intelligent Power Unit, Intelligent Console, Intelligent Delivery System, Intelligent…Power Medical Interventions, Inc.200901
+6K083527Intelligent Articulating Endoscopic Linear Cutter Reverse with ReloadsPower Medical Interventions, Inc.200801
+6K081826Intelligent Straight and Articular Endoscopic Linear Cutters, Vascular with Reloads…Power Medical Interventions, Inc.200801
+6K073001Idrives, Idrivec, IdrivefPower Medical Interventions, Inc.2007111
+6K073148Idrives, Idrivec, Idrivef with Vascular IndicationsPower Medical Interventions, Inc.20071—
+6K063746Power Extenders Model# PEC200, PES200,PES200SPower Medical Interventions, Inc.200713—
+6K063075Natural Orifice Linear Cutter Digital Loading UnitsPower Medical Interventions, Inc.20060—
+7K180149Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw…Covidien, LLC201812
+7K173031AtriClip LAA Exclusion System with Preloaded PRO·V ClipAtriCure, Inc.20179—
+7K170955Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic DissectorSurgical Instrument Service and Savings Inc.(Dba Medline Ren20170—
+7K143562Reprocessed Cordless Ultrasonic Dissection DeviceSterilmed, Inc.20150—
+7K141371Sonicision Cordless Ultrasonic DissectorCovidien, Formerly Valleylab, A Division of Tyco H20143—
+7K102325Idrive System (I Drive Power Handle, Idrive (Ralc) Single Use Reload)Covidien, LLC, Formerly Registered AS Tyco Healthca20109—
+8K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+8K180010AtriClip FLEX-VAtriCure, Inc.20188—
+8K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+9K181474ArtiClip LAA Exclusion SystemAtriCure, Inc.20187—
+9K160176Signia StaplerCovidien2016514
+9K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+9K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+10K202864Tri-Staple 2.0 ReloadsCovidien20201—
+10K201672Signia Stapler (with new software)Covidien20200—
+10K191413AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA…AtriCure, Inc.20196—
+10K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—
+10K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+11K210293AtriClip LAA Exclusion SystemAtriCure, Inc.20215—
+12K254232ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage…Edwards Lifesciences20260—
+12K233407AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0); AtriClip LAA…AtriCure, Inc.20231—
+12K220305Syntheon LAA Exclusion System, Syntheon LAA Selection GuideSyntheon20222—
+13K252917ATLAAS (Atraumatic Left Atrial Appendage System) (AD)Genesee Biomedical, Inc.20260—
+13K232295LAA Exclusion SystemSyntheon, LLC20231—