DeviceClearance

Product code SFE— Gastroenterology, Urology

HyperSnap Surgical System (HSS)

Classification name
Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
2
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code SFE under 21 CFR 876.1500, via openFDA

Market context for product code SFE

FDA has cleared 2 devices under product code SFE between 2025 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code SFE

Recent clearances under product code SFE

Data sourced from openFDA. This site is unofficial and independent of the FDA.