510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243799Substantially Equivalent

Fetal Pillow

CooperSurgical, Inc., Trumbull CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243799 is the FDA 510(k) clearance record for Fetal Pillow, a class II device, cleared for CooperSurgical, Inc. on under FDA product code PWB (Fetal Head Elevator). FDA's definition for product code PWB reads: "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". FDA records list 103 510(k) clearances for CooperSurgical, Inc., from to . As of , FDA records show no recalls naming K243799.

Clearance record

Decision date
Received
(261 days to decision)
Product code
PWB Fetal Head Elevator
Regulation
21 CFR 884.4350
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
CooperSurgical, Inc. 95 Corporate Dr., Trumbull CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PWB

Trailing 12 months

FDA records hold no clearances under product code PWB in the trailing twelve months.

FDA records show no clearances under product code PWB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260