510(k) K132727

GEM FLOW COUPLER DEVICE AND SYSTEM by Synovis Life Technologies, Inc. — Product Code MVR

K132727 is an FDA 510(k) premarket notification submitted by Synovis Life Technologies, Inc. for the device "GEM FLOW COUPLER DEVICE AND SYSTEM". The FDA issued a decision of Substantially Equivalent on October 22, 2013. The device falls under product code MVR (Device, Anastomotic, Microvascular), a Class II device regulated under 21 CFR 878.4300. Synovis Life Technologies, Inc. has at least 8 other 510(k) clearances on record.