KARL STORZ HYSTEROMAT II

KARL STORZ HYSTEROMAT II is an FDA 510(k)-cleared medical device (K000806) 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 November 29, 2000. Regulation: 8.