PON

Catheter, Balloon, Dilation Of Cervical Canal

Product code

PON

Device name

Catheter, Balloon, Dilation Of Cervical Canal

Device class

Class 2

21 CFR

21 CFR 884.4260

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

Mechanical dilation and softening of the cervix.

Definition text from the FDA device classification database (U.S. federal government work, public domain).