K233813 is an FDA 510(k) clearance for the Bearing nsPVA Express™. This device is classified as a Agents, Embolic, For Treatment Of Uterine Fibroids (Class II - Special Controls, product code NAJ).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 21, 2023, 21 days after receiving the submission on November 30, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K233813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2023 |
| Decision Date | December 21, 2023 |
| Days to Decision | 21 days |
| Submission Type | Special |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | NAJ — Agents, Embolic, For Treatment Of Uterine Fibroids |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |