BIOSOFT DUO DOUBLE LOOP URETERAL STENTS

BIOSOFT DUO DOUBLE LOOP URETERAL STENTS is an FDA 510(k)-cleared medical device (K170422) manufactured by Coloplast Corp.. 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 1, 2017. Regulation: 8.