OMNITECH FULGURATING ELECTRODE

OMNITECH FULGURATING ELECTRODE is an FDA 510(k)-cleared medical device (K050454) manufactured by Omnitech Systems, 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 May 26, 2005. Regulation: 8.