K191264 is an FDA 510(k) clearance for the Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”). This device is classified as a Intrauterine Tamponade Balloon (Class II - Special Controls, product code OQY).
Submitted by Ujenzi Charitable Trust (Medford, US). The FDA issued a Cleared decision on October 30, 2019, 173 days after receiving the submission on May 10, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding.
| 510(k) Number | K191264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2019 |
| Decision Date | October 30, 2019 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | OQY - Intrauterine Tamponade Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | Provides Temporary Control Or Reduction Of Postpartum Uterine Bleeding |