K231786 is an FDA 510(k) clearance for the Gynethotics™ Pessary. This device is classified as a Pessary, Vaginal (Class II - Special Controls, product code HHW).
Submitted by Cosm Medical (Toronto, CA). The FDA issued a Cleared decision on March 6, 2024, 260 days after receiving the submission on June 20, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.3575.
| 510(k) Number | K231786 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2023 |
| Decision Date | March 06, 2024 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHW - Pessary, Vaginal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.3575 |