510(k) K221843

GEM Biover Microvascular Clamps by Synovis Micro Companies Alliance, Inc. — Product Code DXC

K221843 is an FDA 510(k) premarket notification submitted by Synovis Micro Companies Alliance, Inc. for the device "GEM Biover Microvascular Clamps". The FDA issued a decision of Substantially Equivalent on September 14, 2022. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Synovis Micro Companies Alliance, Inc. has at least 4 other 510(k) clearances on record.