510(k) K191268

Force Fiber Suture by Teleflex Medical Incorporated — Product Code GAT

K191268 is an FDA 510(k) premarket notification submitted by Teleflex Medical Incorporated for the device "Force Fiber Suture". The FDA issued a decision of Substantially Equivalent on June 11, 2019. 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.