Foley Catheter with Temperature Sensor

Foley Catheter with Temperature Sensor is an FDA 510(k)-cleared medical device (K200757) manufactured by Deroyal Industries, Inc.. 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 October 14, 2020. Regulation: 8.