Panels › Obstetrics/Gynecology › Product code OQY · Class 2
Intrauterine Tamponade Balloon
Regulation 884.4530
1510(k)s in 12 months (11 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OQY
| Company | 510(k)s | Recalls |
|---|---|---|
| Clinical Innovations, LLC | 2 | 2 |
| Alydia Health | 2 | 0 |
| Cook Incorporated | 2 | 0 |
| Glenveigh Surgical, LLC | 1 | 0 |
| Organon, LLC | 1 | 0 |
| Sinapi Biomedical (Pty) , Ltd. | 1 | 0 |
| Ujenzi Charitable Trust | 1 | 0 |
| Utah Medical Products, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2015 | Clinical Innovations, LLC The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY.
Intended for use in providing temporary control or reduction of postpartum uterine bleeding. Terminated |
OQY | K150573 |
| Jan 27, 2015 | Clinical Innovations, LLC Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO Terminated |
OQY | None listed |
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