SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY

SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY is an FDA 510(k)-cleared medical device (K003608) manufactured by Aesculap, 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 February 19, 2001. Regulation: 8.