Fetal Head Elevator
The Fetal Head Elevator is an obstetrics/gynecology device used to elevate the fetal head and facilitate delivery in women undergoing a cesarean section at full cervical dilation or following a failed instrumental vaginal delivery, helping to safely disengage the fetal head from the pelvis. It is classified as FDA Class II under regulation 21 CFR 884.4350, requiring 510(k) premarket notification clearance and compliance with general and special controls. The product code is PWB and it falls under the Obstetrics/Gynecology medical specialty. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PWB
- Device Class
- FDA class 2
- Regulation Number
- 884.4350
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.