PRECISA BIOPSY NEEDLE

PRECISA BIOPSY NEEDLE is an FDA 510(k)-cleared medical device (K002944) manufactured by H.S. Hospital Service S.R.L.. 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 18, 2000. Regulation: 8.