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Fetal Head Elevator

FDA product code PWB · 1 cleared devices

Class 2 Obstetrics/Gynecology
Regulation
21 CFR 884.4350
Review panel
OB
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-08-29 – 2025-08-29

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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