SCKOONCUP
FDA 510(k) clearance K120107 · decided 2012-09-18
Clearance details
- K-number
- K120107
- Device name
- SCKOONCUP
- Applicant
- Sckoon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-13
- Decision date
- 2012-09-18
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- HHE
- Device class
- 2
- Regulation number
- 884.5400
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Miami Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Sunny Cup and Applicator (K233361) | Menstrual Mates | 2024-06-21 |
| MELUNA CLASSIC/SPORT MENSTRUAL CUP (K140626) | Meluna | 2014-07-10 |
| FEMMYCYCLE (K121857) | Femcap Incorporated | 2012-11-15 |
| RHEA CUP (K112165) | Apex Medical Technologies, Inc. | 2012-05-24 |
| BELLECUP (K092985) | Librette, Inc. | 2010-06-28 |
| LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 (K091754) | Lune Group , Ltd. | 2009-11-13 |
| ALICIA MENSTRUAL CUP (K070965) | Alicia International Pty , Ltd. | 2008-03-05 |
| MOONCUP (K060852) | Mooncup Limited | 2006-12-26 |
| MOONCUP, STYLE A & B (K040335) | Mooncup, LLC | 2005-03-30 |
| THE DIVACUP MENSTRUAL SOLUTION (K021356) | Diva International, Inc. | 2002-07-16 |
| INSTEAD, SOFTCUP (K971303) | Ultrafem, Inc. | 1997-06-06 |
| SOFTCUP(TM):2 (K920792) | Ultrafem, Inc. | 1993-10-05 |
Recalls involving this device
No recalls on record reference this clearance.