HELLER TRANSILLUMINATING STYLETTE

HELLER TRANSILLUMINATING STYLETTE is an FDA 510(k)-cleared medical device (K925061) manufactured by Device Resources. 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 June 26, 1994. Regulation: 8.