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FDA 510(k)

Fetal Pillow

K-Number: K243799 · 2025-08-29

ApplicantCooperSurgical, Inc.
Decision Date2025-08-29
Product CodePWB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Fetal Pillow is a medical device manufactured by CooperSurgical, Inc.. It received FDA 510(k) clearance on 2025-08-29 under approval number K243799. The device is classified under product code PWB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fetal Pillow?

Fetal Pillow is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by CooperSurgical, Inc.. The 510(k) number is K243799.

When was Fetal Pillow approved by the FDA?

Fetal Pillow received FDA 510(k) clearance on 2025-08-29, under approval number K243799.

What company makes Fetal Pillow?

Fetal Pillow is manufactured by CooperSurgical, Inc..

What is the FDA product code for Fetal Pillow?

The FDA product code for Fetal Pillow is PWB.

Other Devices by CooperSurgical, Inc.

K151845Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula K170560SAGE Vitrification Kit and SAGE Vitrification Warming Kit K180429Advincula Delineator Uterine Manipulator K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K191291Wallace Dual Lumen Oocyte Recovery System

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Related Devices (Code: PWB)

DEN150053FETAL PILLOWSafe Obstetric Systems, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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