BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES

BIOPSY SCIENCES, LLC. MAXI-CELL BIOPSY NEEDLES is an FDA 510(k)-cleared medical device (K021847) manufactured by Biopsy Sciences, LLC. 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 2, 2002. Regulation: 8.