PFJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4260
- Medical specialty
- Obstetrics/Gynecology
- Flags
- Third-party review eligible
- FDA definition
- Mechanical dilation of the cervical canal for labor.
- Adverse events (MAUDE)
- 2017: 11 · 2018: 12 · 2019: 26 · 2020: 20 · 2021: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| UTAH CVX-RIPE (K143424) | Utah Medical Products, Inc. | 2015-08-28 |
| COOK CERVICAL RIPENING BALLOON (K131206) | Cook, Inc. | 2013-09-27 |
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