510(k) K192490

Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch by Teleflex Medical — Product Code GAT

K192490 is an FDA 510(k) premarket notification submitted by Teleflex Medical for the device "Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch". The FDA issued a decision of Substantially Equivalent on March 30, 2020. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Teleflex Medical has at least 10 other 510(k) clearances on record.