Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
FDA 510(k) K170622 · Cook Incorporated
510(k) numberK170622
Submission
- Device name
- Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- March 1, 2017
- Decision date
- March 31, 2017
- 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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| 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 Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component cleared by the FDA?
Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component (K170622) received a 510(k) decision of Substantially Equivalent on March 31, 2017, 30 days after the submission was received.
What is the product code of K170622?
The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.