Home / 510(k) Clearances / K243799

510(k) K243799

Fetal Pillow by CooperSurgical, Inc. — Product Code PWB

K243799 is an FDA 510(k) premarket notification submitted by CooperSurgical, Inc. for the device "Fetal Pillow". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code PWB (Fetal Head Elevator), a Class II device regulated under 21 CFR 884.4350. CooperSurgical, Inc. has at least 10 other 510(k) clearances on record.

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.

Other clearances by CooperSurgical, Inc.

  • K250438 — CooperSurgical Milex® Pessaries (April 11, 2025)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
  • K201086 — Advincula Delineator Uterine Manipulator (May 21, 2020)
  • K200038 — Endosee System (February 5, 2020)
  • K191020 — G210 InviCell Plus with SignipHy pH monitoring (January 14, 2020)
  • K191291 — Wallace Dual Lumen Oocyte Recovery System (June 12, 2019)
  • K190639 — Endosee System (May 15, 2019)
  • K182959 — Wallace Dual Lumen Oocyte Recovery System (May 10, 2019)
  • K183020 — Endosee System (January 31, 2019)
  • K180429 — Advincula Delineator Uterine Manipulator (March 14, 2018)

Other clearances for product code PWB

FDA data resources