510(k) K230849
- Device
- ELLAVI UBT
- Applicant
- Sinapi Biomedical (Pty) , Ltd.
- 510(k) number
- K230849
- Product code
- OQY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-13
- Date received
- 2023-03-28
- Regulation
- 884.4530
- Classification name
- Intrauterine Tamponade Balloon
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chris de Villiers
- Address
- 1 Lelie Rd. Stellenbosch ZA 7600 7600
FDA Registration Numbers#
- 1216677
- 3010419931
- 1721676
- 1820334
- 1825146
- 3030447506
- 3017425145
- 2025851
- 3014279513
- 1718873
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 |
| 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 |
| K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016-01-14 |
| 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 |