Home / Device Classification / NWB

NWB — Endoscope, Accessories, Narrow Band Spectrum Class II

FDA Device Classification

Classification Details

Product Code
NWB
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K222020sonoscape medicalHD-550 Video Endoscope SystemSeptember 8, 2022
K211882sonoscape medicalHD-550 Video Endoscope SystemApril 1, 2022
K173921sonoscape medicalHD-500 Video Endoscope SystemSeptember 5, 2018
K133538olympus corporation of the americasVISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOAugust 7, 2014
K100584olympus medical systems corporationEVIS EXERAII 180 SYSTEMJuly 2, 2010
K090980olympus winter and ibeHD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LJune 29, 2009
K072957olympus medical systems corporationEVIS EXERA II 180 SYSTEMMarch 18, 2008
K062049olympus medical systems corporationEVIS EXERA II 180 SYSTEMSeptember 22, 2006
K051645olympus medical systems corporationEVIS EXERA 160A SYSTEMOctober 13, 2005