FG-36UX FIBER ULTRASOUND GASTROSCOPE

FG-36UX FIBER ULTRASOUND GASTROSCOPE is an FDA 510(k)-cleared medical device (K041396) manufactured by Pentax Precision Instrument Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 8, 2004. Regulation: 8.