510(k) K172016

Force Fiber Fusion Suture by Teleflex Medical Incorporated — Product Code GAT

K172016 is an FDA 510(k) premarket notification submitted by Teleflex Medical Incorporated for the device "Force Fiber Fusion Suture". The FDA issued a decision of Substantially Equivalent on October 3, 2017. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Teleflex Medical Incorporated has at least 2 other 510(k) clearances on record.