← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
DEVICE CLASS
Class II
REGULATION
21 CFR 876.1500
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K261880Fujifilm Corporation · 510k2026-07-02
K261260Olympus Medical Systems Corporation · 510k2026-06-24
K251734Proverum Limited · 510k2025-09-24
K250462Univlabs Technologies Private Limited · 510k2025-08-11
K250204Shenzhen Sophway Technology Co., Ltd. · 510k2025-07-01
K243260Fujifilm Corporation · 510k2025-04-11
K242067Olympus Corporations of the Americas · 510k2025-04-02
K243321Guangzhou Red Pine Medical Instrument Co., Ltd. · 510k2025-02-07
Related on SPEQ
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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