ELECTRODES/PROBES/DEVICES

ELECTRODES/PROBES/DEVICES is an FDA 510(k)-cleared medical device (K974637) manufactured by Ximed/Prosure/Injectx. 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 January 6, 1998. Regulation: 8.