Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2022-10-28 under approval 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. It is manufactured by Cook Incorporated. The 510(k) number is K223098.

When was Bakri Essential Postpartum Balloon approved by the FDA?

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

What company makes Bakri Essential Postpartum Balloon?

Bakri Essential Postpartum Balloon is manufactured by Cook Incorporated.

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

NCT07019623 U-CaVIT Versus Standard of Care for Prevention of Atonic Postpartum Hemorrhage After Cesarean Section in High-risk Women. RECRUITING

Other Devices by Cook Incorporated

K160884CXI Support Catheter K161822Torcon NB Advantage Catheters K161496Turbo-Flo PICC Sets K160217uVue HSG/SHG Catheter K161002Aprima Smartesis Centesis Pump K153761Emergency Transtracheal Airway Catheter

View all 147 devices →

Related Devices (Code: OQY)

K153591ebb Complete Tamponade SystemClinical Innovations, LLC K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated K191264Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust K201199Jada SystemAlydia Health K212757Jada SystemAlydia Health K230849ELLAVI UBTSinapi Biomedical (Pty) , Ltd.

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.

↑