K233548 is an FDA 510(k) clearance for the Uresta?, 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 review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K233548 FDA.gov |
| FDA Decision | Cleared 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 |