510(k) Report

Devices descending from K030170

4 later devices reach Reusable Smartstitch Suture Device, Models OM-8007, OM-8500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062244Opus Smartstich Suture Device with Perfectpasser ConnectorArthrocare Corp.20063—
+2K121306Smartstitch M-Connector Ultra Smartstitch Suture Device Handle Smartstitch Suture Device…Arthocare Corporation20121—
+2K070671Opus Smartstitch Suture DeviceArthrocare Corp.200702
+3K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid…ArthroCare Corporation201701