510(k) K101252

NEOTRACT ANCHOR SYSTEM MODEL: REF 11208 by Neotract, Inc. — Product Code GAT

K101252 is an FDA 510(k) premarket notification submitted by Neotract, Inc. for the device "NEOTRACT ANCHOR SYSTEM MODEL: REF 11208". The FDA issued a decision of Substantially Equivalent on July 15, 2010. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Neotract, Inc. has at least 10 other 510(k) clearances on record.