PWB · Class II · 21 CFR 884.4350

FDA Product Code PWB: Fetal Head Elevator

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.

Leading manufacturers include CooperSurgical, Inc..

2
Total
1
Cleared
439d
Avg days
2017
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 261d recently vs 617d historically

FDA 510(k) Cleared Fetal Head Elevator Devices (Product Code PWB)

2 devices
1–2 of 2
Cleared Aug 29, 2025
Fetal Pillow
K243799
CooperSurgical, Inc.
Obstetrics & Gynecology · 261d

About Product Code PWB - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PWB since 2017, with 1 receiving FDA clearance (average review time: 439 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under PWB have taken an average of 261 days to reach a decision - down from 617 days historically, suggesting improved FDA processing for this classification.

PWB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →