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

Fetal Head Elevator

21 CFR 884.4350 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

PWB is the FDA product code for Fetal Head Elevator, a class II device type, regulated under 21 CFR 884.4350. FDA's definition for this code 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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PWB
Device name
Fetal Head Elevator
FDA definition
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.
Regulation
21 CFR 884.4350
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code PWB

By decision year
2 clearances under product code PWB with a decision year between 2017 and 2025, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PWB by decision year
YearClearances
20171
20251

Applicants with the most clearances

Product code PWB
Applicants holding the most 510(k) clearances under product code PWB
ApplicantClearances
CooperSurgical, Inc.1
Safe Obstetric Systems, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code