Paragonix SherpaPak Pancreas Transport System

Paragonix SherpaPak Pancreas Transport System is an FDA 510(k)-cleared medical device (K191440) manufactured by Paragonix Technologies. 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 December 19, 2019. Regulation: 8.