Monoject Enteral Syringe with ENFit Connector

Monoject Enteral Syringe with ENFit Connector is an FDA 510(k)-cleared medical device (K161963) manufactured by Covidien. 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 August 31, 2016. Regulation: 8.