FS-38X, FIBER SIGMOIDOSCOPE

FS-38X, FIBER SIGMOIDOSCOPE is an FDA 510(k)-cleared medical device (K951572) 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 June 26, 1995. Regulation: 8.