510(k) K181774

Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture by Teleflex Medical Incorporated — Product Code GAT

K181774 is an FDA 510(k) premarket notification submitted by Teleflex Medical Incorporated for the device "Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture". The FDA issued a decision of Substantially Equivalent on October 10, 2018. 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.