FDA Product Code SFE: Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
To Allow For Visualization Of Body Cavities Through An Endoscope With Real Time Augmentation Of Video Images Via Software To A Monitor.
Leading manufacturers include Hypervision Surgical.
FDA 510(k) Cleared Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation Devices (Product Code SFE)
About Product Code SFE - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SFE since 2025, with 1 receiving FDA clearance (average review time: 145 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.
SFE devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →