FDA product code PWB: Fetal Head Elevator
PWB is the FDA product code for fetal head elevator. It is a Class II device, regulated under 21 CFR 884.4350 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 1 510(k) submission under PWB, 1 in the last five years. The average 510(k) review took 261 days (median 261); 261 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Fetal Head Elevator |
| Device class | Class II |
| Regulation | 21 CFR 884.4350 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for PWB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 261 |
Compare with all 510(k) review times · Search every PWB clearance
Top PWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| CooperSurgical, Inc. | 1 | 2025-08-29 |
Most recent PWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243799 | CooperSurgical, Inc. | Fetal Pillow | 2025-08-29 | 261 |
Recalls for PWB devices
openFDA lists no recalls for product code PWB.
Frequently asked questions
What is FDA product code PWB?
PWB is the FDA product code for fetal head elevator. It is a Class II device, regulated under 21 CFR 884.4350 and reviewed by the Obstetrics and Gynecology panel.
What device class is PWB?
Class II, regulation 21 CFR 884.4350. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWB?
Across 1 cleared submissions the average was 261 days from receipt to decision (median 261).
Which companies have the most PWB clearances?
CooperSurgical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PWB
- Run a recall and safety report across every PWB manufacturer
- Watch product code PWB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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