PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)

PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) is an FDA 510(k)-cleared medical device (K131902) manufactured by Pentax Medical Company. 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 April 9, 2014. Regulation: 8.