FDA 510(k)

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

Номер K: K191264 · 2019-10-30

Дата решения2019-10-30

Код продуктаOQY

Консультативный комитетOB

РешениеSubstantially Equivalent

Описание устройства

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

Часто задаваемые вопросы

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. The listed applicant is Ujenzi Charitable Trust. The 510(k) number is K191264.

When did Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) receive FDA 510(k) clearance?

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

Who is the listed applicant for Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)?

The FDA 510(k) record lists Ujenzi Charitable Trust as the applicant. This does not by itself establish the device manufacturer.

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OQY)

K253642Jada System (Jada-2002)Organon, LLC K230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K223098Bakri Essential Postpartum BalloonCook Incorporated K212757Jada SystemAlydia Health K201199Jada SystemAlydia Health K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated

Официальный источник

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