BIOPSY NEEDLE GUIDE KIT, STERILE

BIOPSY NEEDLE GUIDE KIT, STERILE is an FDA 510(k)-cleared medical device (K871467) manufactured by Amedic USA. 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 August 20, 1987. Regulation: 8.