K230849 is an FDA 510(k) clearance for the ELLAVI UBT. This device is classified as a Intrauterine Tamponade Balloon (Class II - Special Controls, product code OQY).
Submitted by Sinapi Biomedical (Pty) , Ltd. (Stellenbosch, ZA). The FDA issued a Cleared decision on November 13, 2023, 230 days after receiving the submission on March 28, 2023.
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 | K230849 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2023 |
| Decision Date | November 13, 2023 |
| Days to Decision | 230 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 |