Panels › Obstetrics/Gynecology › Product code HHE · Class 2
Cup, Menstrual
Regulation 884.5400
0510(k)s in 12 months (16 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in HHE
| Company | 510(k)s | Recalls |
|---|---|---|
| Mooncup Limited | 2 | 0 |
| Ultrafem, Inc. | 2 | 0 |
| Alicia International Pty , Ltd. | 1 | 0 |
| Apex Medical Technologies, Inc. | 1 | 0 |
| CooperSurgical, Inc. | 1 | 0 |
| Diva International, Inc. | 1 | 0 |
| Femcap Incorporated | 1 | 0 |
| The Keeper Co. | 1 | 0 |
| Librette, Inc. | 1 | 0 |
| Lune Group , Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 21, 2024 | K233361 | Sunny Cup and Applicator Menstrual Mates | HHE |
| Jul 10, 2014 | K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP Meluna | HHE |
| Nov 15, 2012 | K121857 | FEMMYCYCLE Femcap Incorporated | HHE |
| Sep 18, 2012 | K120107 | SCKOONCUP Sckoon, Inc. | HHE |
| May 24, 2012 | K112165 | RHEA CUP Apex Medical Technologies, Inc. | HHE |
| Jun 28, 2010 | K092985 | BELLECUP Librette, Inc. | HHE |
| Nov 13, 2009 | K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 Lune Group , Ltd. | HHE |
| Mar 5, 2008 | K070965 | ALICIA MENSTRUAL CUP Alicia International Pty , Ltd., AU | HHE |
| Dec 26, 2006 | K060852 | MOONCUP Mooncup Limited, GB | HHE |
| Mar 30, 2005 | K040335 | MOONCUP, STYLE A & B Mooncup, LLC | HHE |
| Jul 16, 2002 | K021356 | THE DIVACUP MENSTRUAL SOLUTION Diva International, Inc., CA | HHE |
| Jun 6, 1997 | K971303 | INSTEAD, SOFTCUP Ultrafem, Inc. | HHE |
| Oct 5, 1993 | K920792 | SOFTCUP(TM):2 Ultrafem, Inc. | HHE |
| Apr 18, 1991 | K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) CooperSurgical, Inc. | HHE |
| May 6, 1987 | K870803 | THE KEEPER The Keeper Co. | HHE |
| Feb 12, 1981 | K803250 | TASSAWAY Plastic Applications, Inc. | HHE |
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