PNU

Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

Product code

PNU

Device name

Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery

Device class

Class 2

21 CFR

21 CFR 884.5210

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

Designed to provide counter-pressure to the perianal region during vaginal childbirth to help reduce the likelihood of Cesarean delivery

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