TWINTRODE ELC 134 ELECTRODE

TWINTRODE ELC 134 ELECTRODE is an FDA 510(k)-cleared medical device (K012785) manufactured by Healthtronics Surgical Services, 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 November 15, 2001. Regulation: 8.