FDA Product Code
FDA Product Code HHE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.5400
510(k) Clearances — 16 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233361 | Sunny Cup and Applicator | Menstrual Mates | 2024-06-21 | Traditional | PDF ↗ |
| K140626 | MELUNA CLASSIC/SPORT MENSTRUAL CUP | Meluna | 2014-07-10 | Traditional | PDF ↗ |
| K121857 | FEMMYCYCLE | Femcap Incorporated | 2012-11-15 | Traditional | PDF ↗ |
| K120107 | SCKOONCUP | Sckoon, Inc. | 2012-09-18 | Traditional | PDF ↗ |
| K112165 | RHEA CUP | Apex Medical Technologies, Inc. | 2012-05-24 | Traditional | PDF ↗ |
| K092985 | BELLECUP | Librette, Inc. | 2010-06-28 | Traditional | PDF ↗ |
| K091754 | LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 | Lune Group , Ltd. | 2009-11-13 | Traditional | PDF ↗ |
| K070965 | ALICIA MENSTRUAL CUP | Alicia International Pty , Ltd. | 2008-03-05 | Traditional | PDF ↗ |
| K060852 | MOONCUP | Mooncup Limited | 2006-12-26 | Traditional | PDF ↗ |
| K040335 | MOONCUP, STYLE A & B | Mooncup, LLC | 2005-03-30 | Traditional | PDF ↗ |
| K021356 | THE DIVACUP MENSTRUAL SOLUTION | Diva International, Inc. | 2002-07-16 | Traditional | PDF ↗ |
| K971303 | INSTEAD, SOFTCUP | Ultrafem, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K920792 | SOFTCUP(TM):2 | Ultrafem, Inc. | 1993-10-05 | Traditional | PDF ↗ |
| K910254 | DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM) | CooperSurgical, Inc. | 1991-04-18 | Traditional | PDF ↗ |
| K870803 | THE KEEPER | The Keeper Co. | 1987-05-06 | Traditional | PDF ↗ |
| K803250 | TASSAWAY | Plastic Applications, Inc. | 1981-02-12 | Traditional | PDF ↗ |
Product code HHE · Class II · Obstetrics/Gynecology. Data: openFDA.