510(k) K153591
- Device
- Ebb Complete Tamponade System
- Applicant
- CLINICAL INNOVATIONS, LLC
- 510(k) number
- K153591
- Product code
- OQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-14
- Date received
- 2015-12-16
- Regulation
- 884.4530
- Classification name
- Intrauterine Tamponade Balloon
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM HAUETER
- Address
- 747 W 4170 S Murray UT US 84123 84123
FDA Registration Numbers#
- 1216677
- 1721676
- 2025851
- 1718873
- 3014279513
- 1825146
- 3030447506
- 1820334
- 3014718111
- 3010419931
Source Documents#
Other 510(k) Records For Product Code OQY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253642 | Jada System (Jada-2002) | Organon, LLC | 2026-05-15 |
| K230849 | ELLAVI UBT | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 |
| K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | 2022-10-28 |
| K212757 | Jada System | Alydia Health | 2021-09-30 |
| K201199 | Jada System | Alydia Health | 2020-08-28 |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) | Ujenzi Charitable Trust | 2019-10-30 |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | Cook Incorporated | 2017-03-31 |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015-03-25 |
| K101535 | BT-CATH | Utah Medical Products, Inc. | 2011-01-11 |
| K091958 | BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM | Glenveigh Surgical, LLC | 2010-04-30 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases