NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE

NIPRO SAFETOUCH TULIP SAFETY FISTULA NEEDLE is an FDA 510(k)-cleared medical device (K071145) 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 September 6, 2007. Regulation: 8.