
Wilson-Cook Medical, Inc.
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Fusion Quattro Extraction Balloon is an FDA 510(k)-cleared medical device (K200247) manufactured by Wilson-Cook Medical, Inc.. 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 February 26, 2020. Regulation: 8.