INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT

INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT is an FDA 510(k)-cleared medical device (K140263) manufactured by Lexion Medical, LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 4, 2014. Regulation: 8.