510(k) K142309

GEM Flow COUPLER Device and System by Synovis Life Technologies, Inc. — Product Code MVR

K142309 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 September 16, 2014. 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.