Endoscope, Accessories, Narrow Band Spectrum

What Is This Device?

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.

How Is NWB Classified?

Endoscope, Accessories, Narrow Band Spectrum is FDA product code NWB, Class 2, 21 CFR 876.1500.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 3 clearances under this code; the FDA took a median of 253 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 19 recalls under this product code since 2016. None was by a company in China. 2 are Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (7), Process design (1) and Labeling design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.