ORTHO ALL-FLEX DIAPHRAGM
FDA 510(k) clearance K080040 · decided 2008-08-25
Clearance details
- K-number
- K080040
- Device name
- ORTHO ALL-FLEX DIAPHRAGM
- Applicant
- Johnson & Johnson Produtos Profissionais Ltda.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-07
- Decision date
- 2008-08-25
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- HDW
- Device class
- 2
- Regulation number
- 884.5350
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Claremont, NH, 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 |
|---|---|---|
| CAYA CONTOURED DIAPHRAGM (K140305) | Kessel Medintim GmbH | 2014-08-26 |
| 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.