HHE
- Product code
- HHE
- Device name
- Cup, Menstrual
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.5400
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 16 (all years; only the last 3 years are listed here)
FDA classification definition
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K233361 | 2024-06-21 | Menstrual Mates | Sunny Cup and Applicator |
Official FDA classification page: HHE
Classification and pathway per current FDA publications. Data from openFDA (CC0).