Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301

Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301 is an FDA 510(k)-cleared medical device (K150234) manufactured by Myriad Medical, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 30, 2015. Regulation: 8.