ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 is an FDA 510(k)-cleared medical device (K062259) manufactured by Iscience Surgical. 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 14, 2006. Regulation: 8.