Home / Device Classification / SFE

SFE — Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation Class II

FDA Device Classification

Classification Details

Product Code
SFE
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
SU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

To allow for visualization of body cavities through an endoscope with real time augmentation of video images via software to a monitor.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253984covidienInstrument Exit Point on Touch Surgery™ AideJune 4, 2026
K250268hypervision surgicalHyperSnap Surgical System (HSS)June 24, 2025