DeviceClearance

Product code PWB— Obstetrics/Gynecology

FETAL PILLOW

Classification name
Fetal Head Elevator
Device class
Class 2
Regulation
21 CFR 884.4350
Advisory panel
Obstetrics/Gynecology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PWB under 21 CFR 884.4350, via openFDA

Market context for product code PWB

FDA has cleared 2 devices under product code PWB between 2017 and 2025, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PWB

Recent clearances under product code PWB

Data sourced from openFDA. This site is unofficial and independent of the FDA.