
United State Endoscopy Group, Inc.
Free shipping on orders over $99 · 30-day returns
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON is an FDA 510(k)-cleared medical device (K163424) manufactured by United State Endoscopy Group, 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 January 3, 2017. Regulation: 8.