510(k) Report

Devices descending from K042031

14 later devices reach Opus Speedstitch Suture Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…ArthroCare Corporation201701
+1K071796Capsew Plication SystemCayenne Medical, Inc.20070—
+1K061386Anchor Band Suturing System, Model SR-ABAnulex Technologies, Inc.200611—
+2K100572Versaclose, Model VC-200-01Anulex Technologies, Inc.20107—
+2K062307Xclose Tissue Repair System, Model SRSAnulex Technologies, Inc.20069—
+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—
+4K113805Fixate Tissue BandAnulex Technologies, Inc.20123—
+4K113400Fixate Tissue BandAnulex Technologies, Inc.20114—
+4K112849Fixate Tissue BandAnulex Technologies, Inc.20115—
+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—