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FDA 510(k)

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

K-Number: K191264 · 2019-10-30

ApplicantUjenzi Charitable Trust
Decision Date2019-10-30
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is a medical device manufactured by Ujenzi Charitable Trust. It received FDA 510(k) clearance on 2019-10-30 under approval number K191264. The device is classified under product code OQY. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is a medical device that received FDA 510(k) clearance on 2019-10-30. It is manufactured by Ujenzi Charitable Trust. The 510(k) number is K191264.

When was Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) approved by the FDA?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) received FDA 510(k) clearance on 2019-10-30, under approval number K191264.

What company makes Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is manufactured by Ujenzi Charitable Trust.

What is the FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

The FDA product code for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) is OQY.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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