XPS 3000 SYSTEM

XPS 3000 SYSTEM is an FDA 510(k)-cleared medical device (K002224) manufactured by Medtronic Xomed. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 3, 2000. Regulation: 8.