5 STAR MEDICAL ENDOSCOPE

5 STAR MEDICAL ENDOSCOPE is an FDA 510(k)-cleared medical device (K963354) manufactured by Five Star Medical, 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 September 7, 1997. Regulation: 8.