PWB

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Fetal Head Elevator

Device class

Class II (moderate risk)

Regulation

21 CFR 884.4350

Medical specialty

Obstetrics/Gynecology

FDA 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.

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