510(k) K153076

silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL by Teleflexmedical, Inc. — Product Code GAT

K153076 is an FDA 510(k) premarket notification submitted by Teleflexmedical, Inc. for the device "silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL". The FDA issued a decision of Substantially Equivalent on June 16, 2016. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Teleflexmedical, Inc. has at least 10 other 510(k) clearances on record.