FDA Product Code
FDA Product Code OQY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.4530
510(k) Clearances — 11 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253642 | Jada System (Jada-2002) | Organon, LLC | 2026-05-15 | Traditional | PDF ↗ |
| K230849 | ELLAVI UBT | Sinapi Biomedical (Pty) , Ltd. | 2023-11-13 | Traditional | PDF ↗ |
| K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | 2022-10-28 | Special | PDF ↗ |
| K212757 | Jada System | Alydia Health | 2021-09-30 | Special | PDF ↗ |
| K201199 | Jada System | Alydia Health | 2020-08-28 | Traditional | PDF ↗ |
| K191264 | Every Second Matters-Uterine Balloon Tamponade (ESM-UBT) | Ujenzi Charitable Trust | 2019-10-30 | Traditional | PDF ↗ |
| K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component | Cook Incorporated | 2017-03-31 | Special | PDF ↗ |
| K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016-01-14 | Special | PDF ↗ |
| K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015-03-25 | Special | PDF ↗ |
| K101535 | BT-CATH | Utah Medical Products, Inc. | 2011-01-11 | Traditional | PDF ↗ |
| K091958 | BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM | Glenveigh Surgical, LLC | 2010-04-30 | Traditional | PDF ↗ |
Product code OQY · Class II · Obstetrics/Gynecology. Data: openFDA.