FUJINON STERILE OVERTUBES

FUJINON STERILE OVERTUBES is an FDA 510(k)-cleared medical device (K091773) manufactured by Fujinon, 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 6, 2009. Regulation: 8.