DeviceClearance

Product code NWB— Gastroenterology, Urology

EVIS EXERA II 180 SYSTEM

Classification name
Endoscope, Accessories, Narrow Band Spectrum
Device class
Class 2
Regulation
21 CFR 876.1500
Advisory panel
Gastroenterology, Urology
Total cleared
9
First cleared
Most recent

FDA classification definition

“Alternative mode of visualization using narrow bands from the visible spectrum for illumination and indicated for endoscopy and endoscopic surgery of the upper and lower diagestive tract and urinary tract.”

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

Market context for product code NWB

FDA has cleared 9 devices under product code NWB between 2005 and 2022, filed by 4 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 NWB

Adverse events under product code NWB

product code NWB
Malfunction
12,503
Total
12,503

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 NWB

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