ENDOMEDIX Y-ADAPTER

ENDOMEDIX Y-ADAPTER is an FDA 510(k)-cleared medical device (K934170) manufactured by Endomedix. 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 January 10, 1994. Regulation: 8.