FG-36UX, FIBER ULTRASOUND GASTROSCOPE

FG-36UX, FIBER ULTRASOUND GASTROSCOPE is an FDA 510(k)-cleared medical device (K010740) manufactured by Pentax Precision Instrument Corp.. 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 16, 2001. Regulation: 8.