MODIFICATION TO TEMNO BIOPSY NEEDLES

MODIFICATION TO TEMNO BIOPSY NEEDLES is an FDA 510(k)-cleared medical device (K024120) manufactured by Allegiance Healthcare 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 January 14, 2003. Regulation: 8.