PWB — Fetal Head Elevator Class II

FDA Device Classification

Classification Details

Product Code
PWB
Device Class
Class II
Regulation Number
884.4350
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243799coopersurgicalFetal PillowAugust 29, 2025
DEN150053safe obstetric systemsFETAL PILLOWJuly 27, 2017