EndoTool SubQ 2.1

EndoTool SubQ 2.1 is an FDA 510(k)-cleared medical device (K211160) manufactured by Monarch Medical Technologies, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2021. Regulation: 8.