Ion Endoluminal System ; Flexision Biopsy Needle

Ion Endoluminal System ; Flexision Biopsy Needle is an FDA 510(k)-cleared medical device (K182188) manufactured by Intuitive Surgical. 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 February 13, 2019. Regulation: 8.