
Care Fusion
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ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS is an FDA 510(k)-cleared medical device (K141552) manufactured by Care Fusion. 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 September 4, 2014. Regulation: 8.