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HHE — Cup, Menstrual Class II

FDA Device Classification

Classification Details

Product Code
HHE
Device Class
Class II
Regulation Number
884.5400
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233361menstrual matesSunny Cup and ApplicatorJune 21, 2024
K140626melunaMELUNA CLASSIC/SPORT MENSTRUAL CUPJuly 10, 2014
K121857femcap incorporatedFEMMYCYCLENovember 15, 2012
K120107sckoonSCKOONCUPSeptember 18, 2012
K112165apex medical technologiesRHEA CUPMay 24, 2012
K092985libretteBELLECUPJune 28, 2010
K091754lune groupLUNETTE MENSTRUAL CUP, MODELS 1 AND 2November 13, 2009
K070965alicia international ptyALICIA MENSTRUAL CUPMarch 5, 2008
K060852mooncup limitedMOONCUPDecember 26, 2006
K040335mooncupMOONCUP, STYLE A & BMarch 30, 2005
K021356diva internationalTHE DIVACUP MENSTRUAL SOLUTIONJuly 16, 2002
K971303ultrafemINSTEAD, SOFTCUPJune 6, 1997
K920792ultrafemSOFTCUP(TM):2October 5, 1993
K910254coopersurgicalDIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)April 18, 1991
K870803keeperTHE KEEPERMay 6, 1987
K803250plastic applicationsTASSAWAYFebruary 12, 1981