
Covidien, LLC( Formerly Beacon Endoscopic Corp.)
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BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System is an FDA 510(k)-cleared medical device (K150891) manufactured by Covidien, LLC( Formerly Beacon Endoscopic Corp.). 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 30, 2015. Regulation: 8.