Clearance Summary
Jada System (Jada-2002) received FDA 510(k) clearance under submission number K253642, sponsored by Organon, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2026-05-15.
- Submission: K253642
- Applicant / Sponsor: Organon, LLC
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2026-05-15
Classification & Regulation
This clearance is catalogued under FDA product code OQY and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.