AEON Retrieval Bag

AEON Retrieval Bag is an FDA 510(k)-cleared medical device (K180114) manufactured by Lexington Medical, 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 26, 2018. Regulation: 8.