510(k) K121413

CROSSFIX II MEMISCAL REPAIR DEVICE by Cayenne Medical, Inc. — Product Code GAT

K121413 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "CROSSFIX II MEMISCAL REPAIR DEVICE". The FDA issued a decision of Substantially Equivalent on June 4, 2012. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Cayenne Medical, Inc. has at least 10 other 510(k) clearances on record.