KSEA THERMOCOAGULATOR (MODEL 265100 20)

KSEA THERMOCOAGULATOR (MODEL 265100 20) is an FDA 510(k)-cleared medical device (K963852) manufactured by KARL STORZ Endoscopy-America, 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 December 9, 1996. Regulation: 8.