Durex Patronus CloseFit, Durex Patronus Regular

Durex Patronus CloseFit, Durex Patronus Regular is an FDA 510(k)-cleared medical device (K220489) manufactured by Rb Health (Us), LLC. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2022. Regulation: 8.