UTAH CVX-RIPE
FDA 510(k) clearance K143424 · decided 2015-08-28
Clearance details
- K-number
- K143424
- Device name
- UTAH CVX-RIPE
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-12-01
- Decision date
- 2015-08-28
- Days to decision
- 270 days
- Clearance type
- Traditional
- Product code
- PFJ
- Device class
- 2
- Regulation number
- 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Midvale, UT, 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 |
|---|---|---|
| COOK CERVICAL RIPENING BALLOON (K131206) | Cook, Inc. | 2013-09-27 |
Recalls involving this device
No recalls on record reference this clearance.