510(k) Report

Devices descending from K934738

78 later devices reach Autosuture Endoscopic Suturing Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111442V-Loc 180 Absorbable Reload, V-Loc PBT Non-Absorbable Reload, Endo Stitch (TM)…Covidien, Formerly US Surgical A Divison of Tyco H201102
+1K082659Modified Endo StichCovidien Lp, Formerly Registered AS United States200850—
+1K994290Bard Endoscopic Suturing SystemC.R. Bard, Inc.200023—
+1K994087SuperstitchSutura, Inc.20002—
+2K201744Su2ura Approximation DeviceAnchora Medical, Ltd.20210—
+2K153611Coated VICRYU (Polyglactin 91O)Sterile Synthetic Absorbable Suture Cartridges, ETHIBOND…Ethicon, LLC20160—
+2K090419Sils Stitch Endoscopic Suturing DeviceCovidien Lp, Formerly Registered AS United States200947—
+2K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…Ndo Surgical, Inc.20083—
+2K071651Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesEndogastric Solutions, Inc.200715—
+2K062875Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc.200721—
+2K012865Superstitch Vascular Suturing DeviceSutura, Inc.20011—
+2K003102Pare Endoscopic Suturing SystemPare Surgical, Inc.20010—
+3K120299SRS Endoscopic Stapling SystemMedigus, Ltd.20123—
+3K103263Endo Gia Singleuse Duet TRS Reload with TRI0STAPLE TechnologyCovidien, Formerly US Surgical A Divison of Tyco H201045—
+3K082044Ace Stapler, Model F0031Barosense, Inc.20102—
+3K092400Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…Endogastric Solutions, Inc.200962
+3K091832Endogastric Solutions Stomaphyx System with Serosafuse FastenerEndogastric Solutions, Inc.20090—
+3K073644Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc.20083—
+3K070151Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element ApplierEthicon Endo-Surgery, LLC20074—
+3K020940Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00XSutura, Inc.20020—
+4K142113ESOPHYX2 HDEndogastric Solutions, Inc.20145—
+4K132151SRS Endoscopic Stapling SystemMedigus, Ltd.20142—
+4K120258Duet TRS Reloads, Duet TRS Reloads with Tri-Staple Technology, Endo Gia Universal and…Covidien, Formerly US Surgical A Divison of Tyco H20121—
+4K111825Endo Gia (TM) Staplers, DST Series (TM) Gia (TM) Staplers, DST Series (TM) TA (TM)…Covidien, Formerly US Surgical A Divison of Tyco H20114473
+4K110829Ace Stapler and CartridgeBarosense, Inc.20111—
+4K101252Neotract Anchor System Model: Ref 11208Neotract, Inc.20101—
+5K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray…Covidien (Part of Medtronic)20260—
+5K231491TA™ Stapler and Loading Unit with DST Series™ TechnologyCovidien20230—
+5K221013GIA Auto Suture Stapler with DST Series TechnologyCovidien20220—
+5K192720GIA Stapler with Tri-Staple TechnologyCovidien20203—
+5K191070Signia Small Diameter ReloadsCovidien201927
+5K181620Endoscopic Linear Cutting Staplers and Loading Units for Single UseEzisurg (Suzhou) Medical Co., Ltd.20180—
+5K172960easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal…Ezisurg Medical Co., Ltd.20171—
+5K162707Single Use Circular Stapler, Single Use Hemorrhoidal Circular Stapler, Single Patient…Golden Stapler Surgical Co., Ltd.20171—
+5K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…Endogastric Solutions, Inc.20172—
+5K162947Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting…Chongqing Qmi Surgical Co., Ltd.20170—
+5K162710Single Use Circular Stapler, Single Use Hemorrhodial Circular Stapler, Single Patient…Tgs Medical Co., Ltd.20170—
+5K160969ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting StaplerShinemed, LLC20160—
+5K161757Single Use Curved Cutters, Single Use Circular Staplers, Single Use Linear Cutters and…Victor Medical Instruments Co., Ltd.20163—
+5K163098Tri-Staple 2.0 Intelligent CartridgeCovidien, LLC20160—
+5K151163Signia Loading Unit, Tri-Staple 2.0 CartridgeCovidien, LLC20151—
+5K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc.20154—
+5K143129easyEndo Linear Cutting Stapler and Loading Unit for Single Use (Stapler;Loading Unit)Ezisurg Medical Co., Ltd.20150—
+5K143634MUSE SystemMedigus, Ltd.20151—
+5K133938Endo Gia Reinforced Reload with Tri-Staple TechnologyCovidien20141—
+5K132581Microcutter Xchange 30, Microcutter Xchange 30, Blue Staple Cartridge, Blue Staple…Cardica, Inc.201431
+5K131705Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, Formerly US Surgical A Divison of Tyco H20131—
+5K130717Endo Gia ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K122781Reliamax Gastrointestinal Anastomosis and ReloadCovidien, Formerly US Surgical A Divison of Tyco H20130—
+5K121510Idrive Ultra Powered Handle Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20128—
+5K121474Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20121—
+5K120147Ace Stapler and CartridgeBarosense, Inc.20120—
+5K102028Neotract Anchor System Model TAS400Neotract, Inc.20100—
+6K211197Disposable Endoscopic Cutter Stapler and CartridgeChangzhou Waston Medical Appliance Co., Ltd.20230—
+6K222641Signia™ Small Diameter Reloads Including Regular (Round) Tip VersionCovidien202211
+6K221006GIA Stapler with Tri-Staple TechnologyCovidien20221—
+6K211811Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers…Wuxi Beien Surgery Device Co., Ltd.20220—
+6K211458Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear…Ningbo Verykind Medical Device Co., Ltd.20210—
+6K210909easyEndo Lite Linear Cutting Stapler and Loading Unit for Single UseEzisurg Medical Co., Ltd.20210—
+6K200320Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular…M/s. Meril Endo Surgery Private Limited.20210—
+6K202701GIA Stapler with Tri-Staple TechnologyCovidien20202—
+6K173270Tri-Staple 2.0 Reinforced ReloadCovidien201802
+6K172538Disposable Linear Stapler, Disposable Linear CutterChangzhou Kangdi Medical Stapler Co., Ltd.20170—
+6K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.20171—
+6K161137Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip ReloadCardica, Inc.20160—
+6K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.20163—
+6K160176Signia StaplerCovidien2016514
+6K151001MUSE SystemMedigus, Ltd.20150—
+6K140118Microcutter Xchange 30 Stapler, Microcutter Xchange 30 Blue CartridgeCardica, Inc.201412
+6K140170Microcutter Xchange 30 Stapler, Microcutter Xchange 30 White CartridgeCardica, Inc.201412
+6K133762Endo Gia (TM) Extra Long AdapterCovidien, LLC20140—
+6K132493Endo Gia Radial Reload with Tri-Staple TechnologyCovidien, LLC201301
+6K123318Idrive Ultra Powered Handle and Endo Gia AdapterCovidien, Formerly US Surgical A Divison of Tyco H20120—
+7K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.202402
+7K231934GIA™ Stapler with Tri-Staple™ TechnologyCovidien20230—
+7K202864Tri-Staple 2.0 ReloadsCovidien20201—
+7K201672Signia Stapler (with new software)Covidien20200—
+7K170348Signia Four-Bay Smart Charger (to be used with Signia Stapler)Covidien20170—