DeviceClearance

Product code HHE— Obstetrics/Gynecology

ALICIA MENSTRUAL CUP

Classification name
Cup, Menstrual
Device class
Class 2
Regulation
21 CFR 884.5400
Advisory panel
Obstetrics/Gynecology
Total cleared
16
First cleared
Most recent

FDA classification definition

“A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.”

— U.S. Food and Drug Administration, device classification record for product code HHE under 21 CFR 884.5400, via openFDA

Market context for product code HHE

FDA has cleared 16 devices under product code HHE between 1981 and 2024, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HHE

Adverse events under product code HHE

product code HHE
Injury
344
Total
344

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HHE

Data sourced from openFDA. This site is unofficial and independent of the FDA.