510(k) K050611

ENDOTINE RIBBON by Coapt Systems, Inc. — Product Code GAM

K050611 is an FDA 510(k) premarket notification submitted by Coapt Systems, Inc. for the device "ENDOTINE RIBBON". The FDA issued a decision of Substantially Equivalent on April 6, 2005. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. Coapt Systems, Inc. has at least 10 other 510(k) clearances on record.