ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE

ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE is an FDA 510(k)-cleared medical device (K981256) 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 May 11, 1998. Regulation: 8.