Organon Gets FDA’s 510(k) Clearance for Updates to Its Postpartum Hemorrhage Device

Organon has received an additional 510(k) marketing clearance from the FDA for updates to its Jada System for control and treatment of abnormal postpartum uterine bleeding or hemorrhage.

The updated product includes a new kit configuration and a streamlined design to help improve the device’s ease of use, according to the Jersey City, N.J.-based company.

The system is designed to apply a low-level vacuum to encourage normal contraction of the uterus to provide control and treatment of abnormal uterine bleeding or hemorrhage after childbirth. It received its first 510(k) clearance from the FDA in August 2020.