OOA

Hemorrhoid Prevention Pressure Wedge

Product code

OOA

Device name

Hemorrhoid Prevention Pressure Wedge

Device class

Class 2

21 CFR

21 CFR 884.5200

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

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

FDA classification definition

Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.

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