Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is an FDA 510(k)-cleared medical device (K191264) manufactured by Ujenzi Charitable Trust. 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 October 29, 2019. Regulation: 8.