| K-number | K243799 |
| Device name | Fetal Pillow |
| Applicant | CooperSurgical, Inc. |
| Product code | PWB |
| Device class | Class II |
| Decision date | Aug 29, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 884.4350 |
The Fetal Pillow is a single-use, sterile, inflatable silicone balloon device designed to elevate the fetal head and facilitate delivery during Cesarean sections at full dilation or after failed instrumental vaginal delivery. It is indicated for use at gestational age ≥37 weeks and is inflated with saline solution under direct physician control.
The device consists of a dome-shaped silicone balloon attached to a silicone base plate (9.3cm x 5.0cm), connected via 4mm silicone tubing to a two-way stopcock and 60cc polypropylene syringe. Materials include medical-grade silicone, polycarbonate, polyethylene, polypropylene, and isoprene. Sterilization is performed using ETO gas. All components and design specifications are identical to the predicate device.
Not stated in this summary.
Substantial equivalence is established through identical indications for use, device classification, intended use, and technological characteristics compared to predicate device DEN150053. No design changes were made to the subject device, so no additional performance testing was conducted. The submission only updated clinical references in the Instructions for Use based on current published literature (Lassey et al. 2020, Hanley et al. 2020), which support the safety and effectiveness already demonstrated by the predicate.
View the full FDA submission: accessdata.fda.gov