TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE

TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE is an FDA 510(k)-cleared medical device (K073399) manufactured by Envisioneering, 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 December 20, 2007. Regulation: 8.