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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
2
510(K)/PMA CLEARANCES
510k: 2
0
RECALL ENTRIES

Recent clearances

K253984Covidien, LLC · 510k2026-06-04
K250268Hypervision Surgical · 510k2025-06-24

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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