FDA Product Code HFE: Brush, Endometrial
Leading manufacturers include Utepreva, LLC.
FDA 510(k) Cleared Brush, Endometrial Devices (Product Code HFE)
About Product Code HFE - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code HFE since 1985, with 9 receiving FDA clearance (average review time: 290 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under HFE have taken an average of 163 days to reach a decision - down from 306 days historically, suggesting improved FDA processing for this classification.
HFE devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →