K233361 is an FDA 510(k) clearance for the Sunny Cup and Applicator. This device is classified as a Cup, Menstrual (Class II - Special Controls, product code HHE).
Submitted by Menstrual Mates (Lewes, US). The FDA issued a Cleared decision on June 21, 2024, 266 days after receiving the submission on September 29, 2023.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5400. A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow..
| 510(k) Number | K233361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2023 |
| Decision Date | June 21, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HHE - Cup, Menstrual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.5400 |
| Definition | A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow. |