Gem Flow Now (GEM2770-FN)

Gem Flow Now (GEM2770-FN) is an FDA 510(k)-cleared medical device (K233394) manufactured by Synovis Micro Companies Alliance. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 27, 2024. Regulation: 8.