Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
FDA 510(k) clearance K170622 · decided 2017-03-31
Clearance details
- K-number
- K170622
- Device name
- Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
- Applicant
- Cook Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2017-03-01
- Decision date
- 2017-03-31
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OQY
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Bloomington, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Jada System (Jada-2002) (K253642) | Organon, LLC | 2026-05-15 |
| ELLAVI UBT (K230849) | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 |
| Bakri Essential Postpartum Balloon (K223098) | Cook Incorporated | 2022-10-28 |
| Jada System (K212757) | Alydia Health | 2021-09-30 |
| Jada System (K201199) | Alydia Health | 2020-08-28 |
| Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (K191264) | Ujenzi Charitable Trust | 2019-10-30 |
| ebb Complete Tamponade System (K153591) | Clinical Innovations, LLC | 2016-01-14 |
| ebb Complete Tamponade System (K150573) | Clinical Innovations, LLC | 2015-03-25 |
| BT-CATH (K101535) | Utah Medical Products, Inc. | 2011-01-11 |
| BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM (K091958) | Glenveigh Surgical, LLC | 2010-04-30 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S005) | Cook Incorporated | 2009-04-02 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S006) | Cook Incorporated | 2009-03-05 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S004) | Cook Incorporated | 2008-05-08 |
| COOK CHORIONIC VILLUS SAMPLING (CVS) SET (P900007/S002) | Cook Incorporated | 2000-06-12 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007/S001) | Cook Incorporated | 1998-07-08 |
| COOK CHORIONIC VILLUS SAMPLING SET (P900007) | Cook Incorporated | 1994-09-30 |