510(k) Report

Devices descending from K011016

43 later devices reach Lsi Solutions Flexible Suture Placement Device and Accessories Product through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100593Suture Placement Device and Accessories, Flexible Suture Placement Device and…Lsi Solutions, Inc.20105—
+1K082044Ace Stapler, Model F0031Barosense, Inc.20102—
+1K070151Inscope Tissue Anchors, Knotting Elements and Tissue Anchor and Knotting Element ApplierEthicon Endo-Surgery, LLC20074—
+1K062875Endogastric Stomaphyx Device and AccessoriesEndogastric Solutions, Inc.200721—
+1K061770Ethicon Endo Surgery Endoscopic Suturing SystemEthicon Endo-Surgery, Inc.200614—
+1K024301Lsi Endoscopic External Accessory Channel and Accessories ProductLsi Solutions20033—
+1K013990Lifestitch Suturing DeviceEdwards Lifesciences, LLC20020—
+2K222783MD Mattress Suture Placement DeviceLsi Solutions, Inc.20240—
+2K160529Pledgeted COR-SUTURE QUICK LOADLsi Soultions20161—
+2K141206Edwards Lifesciences Thruport Knotting SystemEdwards Lifesciences, LLC20151—
+2K110829Ace Stapler and CartridgeBarosense, Inc.20111—
+2K091832Endogastric Solutions Stomaphyx System with Serosafuse FastenerEndogastric Solutions, Inc.20090—
+2K081853Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc.20088—
+2K073644Endogastric Solutions Stomaphyx Device and AccessoriesEndogastric Solutions, Inc.20083—
+2K073671Plicator GSX Suturing System, Plicator GSX, Plicator Instrument, Plicator GSX Suture…Ndo Surgical, Inc.20083—
+2K073484Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model…Ethicon Endo-Surgery, Inc.20080—
+2K071651Egs Serosafuse Implantable Fasteners, Associated Delivery Devices and AccessoriesEndogastric Solutions, Inc.200715—
+2K033695Irrigation Channel Tubing, Model 100135Byrne Medical, Inc.20031—
+3K203081RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical SutureLsi Solutions20200—
+3K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc.20177—
+3K150882Edwards Suture Fastening SystemEdwards Lifesciences, LLC201501
+3K120299SRS Endoscopic Stapling SystemMedigus, Ltd.20123—
+3K120147Ace Stapler and CartridgeBarosense, Inc.20120—
+3K101252Neotract Anchor System Model: Ref 11208Neotract, Inc.20101—
+3K092400Endogastric Solutions ESOPHYX2 System with Serosafuse Fastener and Accessories, Model…Endogastric Solutions, Inc.200962
+3K092461Irrigation Pump, Irrigation Biopsy Valve, ,Model 00711520, 00711139, 00711140United States Endoscopy Group, Inc.200901
+4K243750SimpleStitch Suturing SystemEnvision Endoscopy20250—
+4K211309endomina systemEndo Tools Therapeutics S.A.20211—
+4K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery201832
+4K142113ESOPHYX2 HDEndogastric Solutions, Inc.20145—
+4K132151SRS Endoscopic Stapling SystemMedigus, Ltd.20142—
+4K102028Neotract Anchor System Model TAS400Neotract, Inc.20100—
+5K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.20260—
+5K210266OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc.20211—
+5K191439OverStitch 2-0 Polypropylene SutureApollo Endosurgery20190—
+5K171307EsophyX2 HD Device with SerosaFuse Fasteners and Accessories, EsophyX Z Device with…Endogastric Solutions, Inc.20172—
+5K143645EsophyX® Z Fastener Delivery DeviceEndogastric Solutions, Inc.20154—
+5K143634MUSE SystemMedigus, Ltd.20151—
+6K231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.20230—
+6K172811EsophyX Z, EsophyX2 HDEndogastric Solutions, Inc.20171—
+6K160960EsophyX® Z Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.20163—
+6K151001MUSE SystemMedigus, Ltd.20150—
+7K240879EsophyX Z+ Device with SerosaFuse Fasteners and AccessoriesEndogastric Solutions, Inc.202402