XprESS Multi-Sinus Dilation Tool

XprESS Multi-Sinus Dilation Tool is an FDA 510(k)-cleared medical device (K142252) manufactured by Entellus Medical, Inc.. This device is classified under the Ear, Nose, Throat specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on October 16, 2014. Regulation: 8.