PWB — Fetal Head Elevator Class II
FDA product code PWB covers "Fetal Head Elevator", a Class II medical device regulated under 21 CFR 884.4350. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 2 recent 510(k) clearances have been granted under this product code.
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.