LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8

LINA LOOP, MODELS: EL-160-4, EL-160-8, EL-200-4, EL-200-8 is an FDA 510(k)-cleared medical device (K070315) manufactured by Lina Medical Aps. 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 October 29, 2007. Regulation: 8.