FDA Product Code HGP: Electrode, Circular (spiral), Scalp And Applicator
Leading manufacturers include Neoventa Medical AB.
FDA 510(k) Cleared Electrode, Circular (spiral), Scalp And Applicator Devices (Product Code HGP)
About Product Code HGP - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code HGP since 1977, with 17 receiving FDA clearance (average review time: 113 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 HGP have taken an average of 91 days to reach a decision - down from 114 days historically, suggesting improved FDA processing for this classification.
HGP devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →