FDA Product Code HFX: Clamp, Circumcision
Leading manufacturers include Medline Industries, Inc. and Medline Industries, LP.
FDA 510(k) Cleared Clamp, Circumcision Devices (Product Code HFX)
About Product Code HFX - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code HFX since 1988, with 27 receiving FDA clearance (average review time: 179 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under HFX have taken an average of 268 days to reach a decision - up from 175 days historically. Manufacturers should account for longer review timelines in current project planning.
HFX devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →