510(k) Report

Devices descending from K972911

22 later devices reach Auto Suture*Endostitch* II** Suture Applier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081853Overstitch Endoscopic Suture SystemApollo Endosurgery, Inc.20088—
+1K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.200611—
+1K013990Lifestitch Suturing DeviceEdwards Lifesciences, LLC20020—
+2K171886OverStitch SX Endoscopic Suturing System (ESS)Apollo Endosurgery, Inc.20177—
+2K100572Versaclose, Model VC-200-01Anulex Technologies, Inc.20107—
+2K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.20069—
+3K243750SimpleStitch Suturing SystemEnvision Endoscopy20250—
+3K211309endomina systemEndo Tools Therapeutics S.A.20211—
+3K181141OverStitch Endoscopic Suturing System and AccessoriesApollo Endosurgery201832
+3K111462Fixate Tissue BandAnulex Technologies, Inc.20116—
+3K091432Xclose Tissue Repair System, Model XC-200-01Anulex Technologies, Inc.20097—
+3K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090—
+4K252400Endomina EZFuse systemEndo Tools Therapeutics S.A.20260—
+4K210266OverStitch Sx Endoscopic Suturing SystemApollo Endosurgery, Inc.20211—
+4K191439OverStitch 2-0 Polypropylene SutureApollo Endosurgery20190—
+4K113805Fixate Tissue BandAnulex Technologies, Inc.20123—
+4K113400Fixate Tissue BandAnulex Technologies, Inc.20114—
+4K112849Fixate Tissue BandAnulex Technologies, Inc.20115—
+5K231553OverStitch NXT Endoscopic Suturing SystemApollo Endosurgery, Inc.20230—
+5K172644Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading…Stimwave Technologies Incorporated20171—
+5K150924A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M.…Anchor Innovation Medical (A.I.M.)20152—
+6K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.20190—