GUARDIAN URETHRAL SHEATH

GUARDIAN URETHRAL SHEATH is an FDA 510(k)-cleared medical device (K141252) manufactured by Solace Therapeutics. 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 June 8, 2014. Regulation: 8.