DeviceClearance

Product code HGE— Obstetrics/Gynecology

AMNIGLOVE & AMNICOT

Classification name
Amniotome
Device class
Class 1
Regulation
21 CFR 884.4530
Advisory panel
Obstetrics/Gynecology
Total cleared
6
First cleared
Most recent

Market context for product code HGE

FDA has cleared 6 devices under product code HGE between 1983 and 1995, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

Top applicants under product code HGE

Recent clearances under product code HGE

Data sourced from openFDA. This site is unofficial and independent of the FDA.