510(k) K063194

TUFFLEX POLYESTER SUTURE by Axya Medical, Inc. — Product Code GAT

K063194 is an FDA 510(k) premarket notification submitted by Axya Medical, Inc. for the device "TUFFLEX POLYESTER SUTURE". The FDA issued a decision of Substantially Equivalent on December 4, 2006. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Axya Medical, Inc. has at least 10 other 510(k) clearances on record.