Panels › Obstetrics/Gynecology › Product code PFJ · Class 2
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Regulation 884.4260
1510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in PFJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook, Inc. | 1 | 0 |
| Ethicon, Inc. | 0 | 1 |
| TZ Medical | 1 | 0 |
| Utah Medical Products, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 29, 2026 | K262570 | TZ Medical Birthing Balloon Kit TZ Medical | PFJ |
| Aug 28, 2015 | K143424 | UTAH CVX-RIPE Utah Medical Products, Inc. | PFJ |
| Sep 27, 2013 | K131206 | COOK CERVICAL RIPENING BALLOON Cook, Inc. | PFJ |
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