PRESTO BREAST BIOPSY DEVICE

PRESTO BREAST BIOPSY DEVICE is an FDA 510(k)-cleared medical device (K120440) manufactured by Sontina Medical, 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 May 16, 2012. Regulation: 8.