510(k) K163142

SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader by ArthroCare Corporation — Product Code GAT

K163142 is an FDA 510(k) premarket notification submitted by ArthroCare Corporation for the device "SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader". The FDA issued a decision of Substantially Equivalent on January 6, 2017. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. ArthroCare Corporation has at least 10 other 510(k) clearances on record.