Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component

Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component is an FDA 510(k)-cleared medical device (K170622) manufactured by Cook Incorporated. 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 March 30, 2017. Regulation: 8.