510(k) Report

Devices descending from K082659

50 later devices reach Modified Endo Stich through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201744Su2ura Approximation DeviceAnchora Medical, Ltd.20210—
+1K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…Ethicon, LLC20160—
+1K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States200947—
+2K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H201102
+2K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+3K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+3K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+4K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+4K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+4K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+4K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+4K191070Signia Small Diameter ReloadsCovidien201927
+4K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+4K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+4K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+4K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+4K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+4K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+4K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+4K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+4K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+4K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+4K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+4K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+4K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+4K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+4K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+4K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+5K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+5K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+5K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+5K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+5K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+5K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+5K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+5K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+5K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+5K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+5K160176Signia StaplerCovidien2016514
+5K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+5K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+5K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+5K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+5K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+6K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+6K202864Tri-Staple 2.0 ReloadsCovidien20201—
+6K201672Signia Stapler (with new software)Covidien20200—
+6K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—