FEMMYCYCLE
FDA 510(k) clearance K121857 · decided 2012-11-15
Clearance details
- K-number
- K121857
- Device name
- FEMMYCYCLE
- Applicant
- Femcap Incorporated
- Decision
- Substantially Equivalent
- Date received
- 2012-06-26
- Decision date
- 2012-11-15
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- HHE
- Device class
- 2
- Regulation number
- 884.5400
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Mission Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| FEMCAP (P020041/S003) | Femcap Incorporated | 2013-08-21 |
| FEM CAP (P020041/S002) | Femcap Incorporated | 2011-10-13 |
| FEMCAP CONTRACEPTIVE BARRIER DEVICE (P020041/S001) | Femcap Incorporated | 2006-02-15 |
| FEMCAP BARRIER CONTRACEPTIVE (P020041) | Femcap Incorporated | 2003-03-28 |