GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL)

GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL) is an FDA 510(k)-cleared medical device (K111059) manufactured by Gyrus Acmi, 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 August 31, 2011. Regulation: 8.