
Fujifilm Medical Systems U.S.A, Inc.
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Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T is an FDA 510(k)-cleared medical device (K143556) manufactured by Fujifilm Medical Systems U.S.A, 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 August 19, 2015. Regulation: 8.