CAYA CONTOURED DIAPHRAGM
FDA 510(k) clearance K140305 · decided 2014-08-26
Clearance details
- K-number
- K140305
- Device name
- CAYA CONTOURED DIAPHRAGM
- Applicant
- Kessel Medintim GmbH
- Decision
- Substantially Equivalent
- Date received
- 2014-02-07
- Decision date
- 2014-08-26
- Days to decision
- 200 days
- Clearance type
- Traditional
- Product code
- HDW
- Device class
- 2
- Regulation number
- 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Frankfurt, DE
- 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 |
|---|---|---|
| ORTHO ALL-FLEX DIAPHRAGM (K080040) | Johnson & Johnson Produtos Profissionais Ltda. | 2008-08-25 |
| MILEX CONTRACEPTIVE DIAPHRAGM, OMNIFLEX DIAPHRAGMS, ARCING DIAPHRAGMS, WIDESEAL DIAPHRAGMS (K063223) | CooperSurgical, Inc. | 2008-01-23 |
| ONCE TM (K800162) | G.D. Searle and Co. | 1980-02-11 |
Recalls involving this device
No recalls on record reference this clearance.