Durex Penck Standard, Durex Penck XL

Durex Penck Standard, Durex Penck XL is an FDA 510(k)-cleared medical device (K200672) 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 5, 2020. Regulation: 8.