Product code PFJ— Obstetrics/Gynecology

COOK CERVICAL RIPENING BALLOON

Classification name: Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Device class: Class 2
Regulation: 21 CFR 884.4260
Advisory panel: Obstetrics/Gynecology
Total cleared: 2
First cleared: 2013-09-27
Most recent: 2015-08-28

FDA classification definition

“Mechanical dilation of the cervical canal for labor.”
— U.S. Food and Drug Administration, device classification record for product code PFJ under 21 CFR 884.4260, via openFDA

Market context for product code PFJ

FDA has cleared 2 devices under product code PFJ between 2013 and 2015, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20151 clearance
20131 clearance

Top applicants under product code PFJ

Utah Medical Products, Inc.1 clearance
Cook, Inc.1 clearance

Recent clearances under product code PFJ

K143424 — UTAH CVX-RIPEUtah Medical Products, Inc.·2015-08-28
K131206 — COOK CERVICAL RIPENING BALLOONCook, Inc.·2013-09-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.