HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE

HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE is an FDA 510(k)-cleared medical device (K013066) 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 December 10, 2001. Regulation: 8.