NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5

NEXUSTKO NEEDLELESS ACCESS DEVICE, MODEL NIS-5 is an FDA 510(k)-cleared medical device (K053129) manufactured by Nexus Medical, LLC. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 7, 2005. Regulation: 8.