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FDA 510(k)

Bakri Essential Postpartum Balloon

K-Number: K223098 · 2022-10-28

ApplicantCook Incorporated
Decision Date2022-10-28
Product CodeOQY
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Bakri Essential Postpartum Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K223098. 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 Bakri Essential Postpartum Balloon?

Bakri Essential Postpartum Balloon is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Cook Incorporated. The 510(k) number is K223098.

When did Bakri Essential Postpartum Balloon receive FDA 510(k) clearance?

Bakri Essential Postpartum Balloon received FDA 510(k) clearance on 2022-10-28, under 510(k) number K223098.

Who is the listed applicant for Bakri Essential Postpartum Balloon?

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

What is the FDA product code for Bakri Essential Postpartum Balloon?

The FDA product code for Bakri Essential Postpartum Balloon is OQY.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07019623U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women.RECRUITING

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Related Devices (Code: OQY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253642Jada System (Jada-2002)Organon, LLCK230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.K212757Jada SystemAlydia HealthK201199Jada SystemAlydia HealthK191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable TrustK170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated

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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