Product code PWB

Device name

Fetal Head Elevator

Medical specialty

Obstetrics/Gynecology

Device class

2

Regulation number

884.4350

Review panel

OB

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To elevate the fetal head and facilitate delivery of the fetus in women requiring a Caesarean Section at full dilation or those requiring a Caesarean Section after a failed instrumental vaginal delivery.

Source

FDA openFDA device classification dataset