K243799
- 510(k) number
- K243799
- Device name
- Fetal Pillow
- Applicant
- CooperSurgical, Inc. CT · US
- Product code
- PWB — Fetal Head Elevator
- Decision date
- 2025-08-29
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Obstetrics/Gynecology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K243799.pdf
Official FDA record: K243799
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.