SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE

SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE is an FDA 510(k)-cleared medical device (K925333) manufactured by Aspen Labs. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 26, 1994. Regulation: 8.