PFJ · Class II · 21 CFR 884.4260

FDA Product Code PFJ: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor

Mechanical Dilation Of The Cervical Canal For Labor.

Leading manufacturers include Cook, Inc. and Utah Medical Products, Inc..

2
Total
2
Cleared
211d
Avg days
2013
Since

FDA 510(k) Cleared Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor Devices (Product Code PFJ)

2 devices
1–2 of 2
Cleared Aug 28, 2015
UTAH CVX-RIPE
K143424
Utah Medical Products, Inc.
Obstetrics & Gynecology · 270d
Cleared Sep 27, 2013
COOK CERVICAL RIPENING BALLOON
K131206
Cook, Inc.
Obstetrics & Gynecology · 151d

About Product Code PFJ - Regulatory Context