
Olympus Surgical Technologies America
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CleverLock Guidewire Locking Device and Biopsy Cap is an FDA 510(k)-cleared medical device (K190164) manufactured by Olympus Surgical Technologies America. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 3, 2019. Regulation: 8.