PKN

Dilator, Cervical, Synthetic, Osmotic

Product code

PKN

Device name

Dilator, Cervical, Synthetic, Osmotic

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)

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

FDA classification definition

Cervical softening and dilation

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