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510(k) K243799

Fetal Pillow by CooperSurgical, Inc. — Product Code PWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2025
Date Received
December 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fetal Head Elevator
Device Class
Class II
Regulation Number
884.4350
Review Panel
OB
Submission Type

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.

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  • K183020 — Endosee System (January 31, 2019)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)

Other clearances for product code PWB