SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader is an FDA 510(k)-cleared medical device (K163142) manufactured by ArthroCare Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 5, 2017. Regulation: 8.