Device type
Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor
Product code PFJ · Class II · 21 CFR 884.4260 · Obstetrics/Gynecology
Mechanical dilation of the cervical canal for labor.
Recent 510(k)s
Oct 29, 2026
K262570
TZ Medical Birthing Balloon Kit
TZ Medical
- PFJ
- Class II
Recent recalls
No recalls in the archive for PFJ.