Clearance Summary
Every Second Matters-Uterine Balloon Tamponade (ESM-UBT) received FDA 510(k) clearance under submission number K191264, sponsored by Ujenzi Charitable Trust. 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 2019-10-30.
- Submission: K191264
- Applicant / Sponsor: Ujenzi Charitable Trust
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2019-10-30
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.