ebb Complete Tamponade System
FDA 510(k) K153591 · Clinical Innovations, LLC
510(k) numberK153591
Submission
- Device name
- ebb Complete Tamponade System
- Applicant
- Clinical Innovations, LLC
Murray, UT, US - Received
- December 16, 2015
- Decision date
- January 14, 2016
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253642 | Jada System (Jada-2002)OQY · Traditional | Organon, LLC | 05/15/2026SE |
| K230849 | Ellavi UbtOQY · Traditional | Sinapi Biomedical (Pty) , Ltd. | 11/13/2023SE |
| K223098 | Bakri Essential Postpartum BalloonOQY · Special | Cook Incorporated | 10/28/2022SE |
| K212757 | Jada SystemOQY · Special | Alydia Health | 09/30/2021SE |
| 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 |
| 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 |
More from Glenveigh Surgical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250298 | Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional | 10/08/2025SE |
| K250897 | Koala Intrauterine Pressure Catheter (IPC-5000E)HFN · Traditional | 05/22/2025SE |
| K223900 | babyLance Safety Heelstick (BLM, BLN, BLP)FMK · Traditional | 02/24/2023SE |
| K150573 | ebb Complete Tamponade SystemOQY · Special | 03/25/2015SE |
| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K110605 | Rom PlusNQM · Traditional | 11/23/2011SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | 01/07/2003SE |
Questions and answers
When was ebb Complete Tamponade System cleared by the FDA?
ebb Complete Tamponade System (K153591) received a 510(k) decision of Substantially Equivalent on January 14, 2016, 29 days after the submission was received.
What is the product code of K153591?
The FDA product code is OQY – Intrauterine Tamponade Balloon, a Class II (moderate risk) device regulated under 21 CFR 884.4530.