HHE

Cup, Menstrual

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-06-21.

NumberDecision dateApplicantDevice nameSummary
K2333612024-06-21Menstrual MatesSunny Cup and ApplicatorPDF

1 summaries are archived here for direct download.

Official FDA classification page: HHE
Classification and pathway per current FDA publications. Data from openFDA (CC0).