FDA 510(k) Applications for Medical Device Product Code "NWB"
(Endoscope, Accessories, Narrow Band Spectrum)

FDA 510(k) Number Applicant Device Name Decision Date
K133538 OLYMPUS CORPORATION OF THE AMERICAS VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE 08/07/2014
K051645 OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA 160A SYSTEM 10/13/2005
K062049 OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II 180 SYSTEM 09/22/2006
K072957 OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II 180 SYSTEM 03/18/2008
K100584 OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERAII 180 SYSTEM 07/02/2010
K090980 OLYMPUS WINTER & IBE GMBH HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L 06/29/2009
K173921 Sonoscape Medical Corp. HD-500 Video Endoscope System 09/05/2018


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