MAMMOTOME EX HAND HELD SYSTEM

MAMMOTOME EX HAND HELD SYSTEM is an FDA 510(k)-cleared medical device (K033700) manufactured by Ethicon Endo-Surgery, 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 19, 2004. Regulation: 8.