510(k) K082518

DUAL NEEDLE SUTURE PASSER SYSTEM by Cayenne Medical, Inc. — Product Code GAT

K082518 is an FDA 510(k) premarket notification submitted by Cayenne Medical, Inc. for the device "DUAL NEEDLE SUTURE PASSER SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 2009. 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.