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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2016 | Ethicon, Inc. Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc.
The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the e Terminated |
PFJ | None listed |
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