Product code OOA

Device name

Hemorrhoid Prevention Pressure Wedge

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.5200

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset