
United States Endoscopy Group, Inc.
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AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM is an FDA 510(k)-cleared medical device (K191559) manufactured by United States 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 July 31, 2019. Regulation: 8.