GF-UE160-AL5 ULTRASOUND ENDOSCOPE

GF-UE160-AL5 ULTRASOUND ENDOSCOPE is an FDA 510(k)-cleared medical device (K051541) manufactured by Olympus America, 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 June 30, 2005. Regulation: 8.