HHE — Cup, Menstrual Class II
FDA product code HHE covers "Cup, Menstrual", a Class II medical device regulated under 21 CFR 884.5400. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 16 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233361 | Menstrual Mates | Sunny Cup and Applicator | Jun 21, 2024 |
| K140626 | Meluna | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Jul 10, 2014 |
| K121857 | Femcap Incorporated | FEMMYCYCLE | Nov 15, 2012 |
| K120107 | Sckoon | SCKOONCUP | Sep 18, 2012 |
| K112165 | Apex Medical Technologies | RHEA CUP | May 24, 2012 |
| K092985 | Librette | BELLECUP | Jun 28, 2010 |
| K091754 | Lune Group | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Nov 13, 2009 |
| K070965 | Alicia International Pty | ALICIA MENSTRUAL CUP | Mar 5, 2008 |
| K060852 | Mooncup Limited | MOONCUP | Dec 26, 2006 |
| K040335 | Mooncup | MOONCUP, STYLE A & B | Mar 30, 2005 |
| K021356 | Diva International | THE DIVACUP MENSTRUAL SOLUTION | Jul 16, 2002 |
| K971303 | Ultrafem | INSTEAD, SOFTCUP | Jun 6, 1997 |
| K920792 | Ultrafem | SOFTCUP(TM):2 | Oct 5, 1993 |
| K910254 | Coopersurgical | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | Apr 18, 1991 |
| K870803 | Keeper | THE KEEPER | May 6, 1987 |
| K803250 | Plastic Applications | TASSAWAY | Feb 12, 1981 |