NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER is an FDA 510(k)-cleared medical device (K100520) manufactured by Nipro 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 March 16, 2010. Regulation: 8.