
Cortek Endoscopy, Inc.
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CORTEK ARTHROSCOPE is an FDA 510(k)-cleared medical device (K000198) manufactured by Cortek Endoscopy, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 10, 2000. Regulation: 8.