MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING

MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING is an FDA 510(k)-cleared medical device (K093899) manufactured by Ethicon Endo-Surgery, 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 April 28, 2010. Regulation: 8.