MAXIFLEX-SEMI FLEX SCOPE

MAXIFLEX-SEMI FLEX SCOPE is an FDA 510(k)-cleared medical device (K062725) manufactured by Technology Delivery Systems, 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 September 28, 2006. Regulation: 8.