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U.S. Department of Health and Human Services

Product Classification

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Device fetal head elevator
Regulation Description Fetal head elevator.
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.
Physical State Inflatable balloon device that provides pressure to the fetal head.
Technical Method Provides pressure via an inflatable balloon inserted into the vaginal canal to elevate the fetal head.
Target Area Vaginal canal.
Regulation Medical Specialty Obstetrics/Gynecology
Review Panel Obstetrics/Gynecology
Product CodePWB
Premarket Review Reproductive, Gynecology and Urology Devices (DHT3B)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 884.4350
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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