FDA Product Code HAE: Rongeur, Manual
Leading manufacturers include KLS-Martin L.P., Aesculap, Inc. and Geister Medizin Technik GmbH.
FDA 510(k) Cleared Rongeur, Manual Devices (Product Code HAE)
About Product Code HAE - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code HAE since 1988, with 36 receiving FDA clearance (average review time: 156 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under HAE have taken an average of 267 days to reach a decision - up from 153 days historically. Manufacturers should account for longer review timelines in current project planning.
HAE devices are reviewed by the Neurology panel. Browse all Neurology devices →