DeviceClearance

Product code NTN— Gastroenterology, Urology

ARTEMIS LIGHT ENGINE

Classification name
Led Light Source
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
9
First cleared
Most recent

FDA classification definition

“Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals”

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

Market context for product code NTN

FDA has cleared 9 devices under product code NTN between 2009 and 2015, filed by 8 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 NTN

Adverse events under product code NTN

product code NTN
Other
1
Total
1

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 NTN

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