ConvertX Nephroureteral Stent System

ConvertX Nephroureteral Stent System is an FDA 510(k)-cleared medical device (K161277) manufactured by Brightwater Medical. 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 November 21, 2016. Regulation: 8.