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 and Covidien, LLC.
2
Total
2
Cleared
160d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation Devices (Product Code SFE)
2 devices
Cleared
Jun 04, 2026
Instrument Exit Point on Touch Surgery™ Aide
Covidien, LLC
General & Plastic Surgery
174d
Cleared
Jun 24, 2025
HyperSnap Surgical System (HSS)
Hypervision Surgical
General & Plastic Surgery
145d
About Product Code SFE - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SFE since 2025, with 2 receiving FDA clearance (average review time: 160 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.