MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER

MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER is an FDA 510(k)-cleared medical device (K021034) manufactured by Tfx Medical, Inc.. 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 June 25, 2002. Regulation: 8.