DeviceClearance

Product code FET— Gastroenterology, Urology

S-357 VIDEO IMAGING SYSTEM

Classification name
Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
100
First cleared
Most recent

FDA classification definition

“To allow for visualization of body cavities through an endoscope by projecting images to a monitor.”

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

Market context for product code FET

FDA has cleared 100 devices under product code FET between 1981 and 2026, filed by 55 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

last 15 years

Top applicants under product code FET

Adverse events under product code FET

product code FET
Injury
313
Malfunction
54,276
Total
54,589

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FET

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