GEM Biover Microvascular Clamps

GEM Biover Microvascular Clamps is an FDA 510(k)-cleared medical device (K221843) manufactured by Synovis Micro Companies Alliance, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 2022. Regulation: 8.