Bakri Essential Postpartum Balloon
FDA 510(k) K223098 · Cook Incorporated
510(k) numberK223098
Submission
- Device name
- Bakri Essential Postpartum Balloon
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- September 30, 2022
- Decision date
- October 28, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQY – Intrauterine Tamponade Balloon
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
provides temporary control or reduction of postpartum uterine bleeding
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| K201199 | Jada SystemOQY · Traditional | Alydia Health | 08/28/2020SE |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (ESM-UBT)OQY · Traditional | Ujenzi Charitable Trust | 10/30/2019SE |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentOQY · Special | Cook Incorporated | 03/31/2017SE |
| K153591 | ebb Complete Tamponade SystemOQY · Special | Clinical Innovations, LLC | 01/14/2016SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | Clinical Innovations, LLC | 03/25/2015SE |
| K101535 | Bt-CathOQY · Traditional | Utah Medical Products, Inc. | 01/11/2011SE |
| K091958 | Belfort-Dildy Obstetric Tamponade SystemOQY · Traditional | Glenveigh Surgical, LLC | 04/30/2010SE |
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Questions and answers
When was Bakri Essential Postpartum Balloon cleared by the FDA?
Bakri Essential Postpartum Balloon (K223098) received a 510(k) decision of Substantially Equivalent on October 28, 2022, 28 days after the submission was received.
What is the product code of K223098?
The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.