Pentax Medical Video Duodenoscope ED32-i10

Pentax Medical Video Duodenoscope ED32-i10 is an FDA 510(k)-cleared medical device (K202365) manufactured by Pentax of America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 31, 2021. Regulation: 8.