K243799 is an FDA 510(k) clearance for the Fetal Pillow. This device is classified as a Fetal Head Elevator (Class II - Special Controls, product code PWB).
Submitted by CooperSurgical, Inc. (Trumbull, US). The FDA issued a Cleared decision on August 29, 2025, 261 days after receiving the submission on December 11, 2024.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4350. 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) Number | K243799 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2024 |
| Decision Date | August 29, 2025 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | PWB — Fetal Head Elevator |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4350 |
| 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. |