510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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HHEClass II

Cup, Menstrual

21 CFR 884.5400 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

HHE is the FDA product code for Cup, Menstrual, a class II device type, regulated under 21 CFR 884.5400. FDA's definition for this code reads: "A menstrual cup is a receptacle placed in the vagina to collect menstrual flow". As of , FDA records hold 16 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
HHE
Device name
Cup, Menstrual
FDA definition
A menstrual cup is a receptacle placed in the vagina to collect menstrual flow.
Regulation
21 CFR 884.5400
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
16
Ingested recalls
0

Clearances, product code HHE

By decision year
16 clearances under product code HHE with a decision year between 1981 and 2024, 2012 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code HHE by decision year
YearClearances
19811
19871
19911
19931
19971
20021
20051
20061
20081
20091
20101
20123
20141
20241

Applicants with the most clearances

Product code HHE
Applicants holding the most 510(k) clearances under product code HHE
ApplicantClearances
Mooncup Limited2
Ultrafem, Inc.2
Alicia International Pty, Ltd.1
Apex Medical Technologies, Inc.1
CooperSurgical, Inc.1
Diva International, Inc.1
Femcap Incorporated1
Librette, Inc.1
Lune Group, Ltd.1
meluna1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order