Pro-Tx Endorectal Balloon (PROT-25)

Pro-Tx Endorectal Balloon (PROT-25) is an FDA 510(k)-cleared medical device (K223249) manufactured by Dxtx Medical, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 9, 2023. Regulation: 8.