INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL

INTACT BREAST LESION EXCISION SYSTEM WITH INTACT EXCISION XL is an FDA 510(k)-cleared medical device (K081057) manufactured by Intact Medical Corporation. 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 June 16, 2008. Regulation: 8.