ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR

ACMI BIPOLAR RECTOSCOPE, MODEL EIWE-BR is an FDA 510(k)-cleared medical device (K021166) manufactured by Acmi-Circon Corporation. 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 May 8, 2002. Regulation: 8.