INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION

INSULATED SPECULUM W/ SMOKE EVACUATOR OPTION is an FDA 510(k)-cleared medical device (K922154) manufactured by Olsen Electrosurgical, Inc.. 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 April 20, 1994. Regulation: 8.