Rezum Delivery Device, Rezum Generator

Rezum Delivery Device, Rezum Generator is an FDA 510(k)-cleared medical device (K190093) manufactured by Nxthera (A Boston Scientific Company). 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 March 24, 2019. Regulation: 8.