K233548 is an FDA 510(k) clearance for the Uresta®. This device is classified as a Pessary, Vaginal (Class II - Special Controls, product code HHW).
Submitted by Resilia, Inc. (Moncton, CA). The FDA issued a Cleared decision on April 3, 2024, 152 days after receiving the submission on November 3, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K233548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 03, 2023 |
| Decision Date | April 03, 2024 |
| Days to Decision | 152 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | HHW - Pessary, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3575 |