
Pentax of America, Inc.
Free shipping on orders over $99 · 30-day returns
Pentax Medical Video Duodenoscope ED34-i10T2 is an FDA 510(k)-cleared medical device (K192245) 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 November 14, 2019. Regulation: 8.