Jada System (Jada-2002)

Jada System (Jada-2002) is an FDA 510(k)-cleared medical device (K253642) manufactured by Organon, 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 May 14, 2026. Regulation: 8.