Endoscope, Accessories, Narrow Band Spectrum

Product Code: NWB

Gastroenterology/Urology General Optical Products / Medical

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.

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 876.1500


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as NWB

2048Endoscope, Accessories, Narrow Band SpectrumEndoscope And Accessories.

Total Product Life Cycle (TPLC) Devices

2048Endoscope, Accessories, Narrow Band SpectrumEndoscope And Accessories.

FDA Consensus Standards

Endoscope, Accessories, Narrow Band Spectrum [33222]21 CFR §876.1500 🔎

Pre-market Notifications for NWB

K222020HD-550 Video Endoscope SystemSonoscape Medical Corp.
K211882HD-550 Video Endoscope SystemSonoscape Medical Corp
K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.
K133538VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NEOLYMPUS CORPORATION OF THE AMERICAS
K100584EVIS EXERAII 180 SYSTEMOLYMPUS MEDICAL SYSTEMS CORPORATION
K090980HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015LOLYMPUS WINTER & IBE GMBH
K072957EVIS EXERA II 180 SYSTEMOLYMPUS MEDICAL SYSTEMS CORPORATION
K062049EVIS EXERA II 180 SYSTEMOLYMPUS MEDICAL SYSTEMS CORPORATION
K051645EVIS EXERA 160A SYSTEMOLYMPUS MEDICAL SYSTEMS CORPORATION

Global Unique Device Identification Database

04953170403811Endoscope, accessories, narrow band spectrum
04953170403392Endoscope, accessories, narrow band spectrum
04953170403385Endoscope, accessories, narrow band spectrum
04953170374692Endoscope, accessories, narrow band spectrum
04953170374623Endoscope, accessories, narrow band spectrum
04953170367311Endoscope, accessories, narrow band spectrum
04953170355929Endoscope, accessories, narrow band spectrum
04953170355493Endoscope, accessories, narrow band spectrum
04953170342943Endoscope, accessories, narrow band spectrum
04953170342912Endoscope, accessories, narrow band spectrum
04953170340321Endoscope, accessories, narrow band spectrum
04953170339967Endoscope, accessories, narrow band spectrum
04953170339899Endoscope, accessories, narrow band spectrum
04953170339523Endoscope, accessories, narrow band spectrum
04953170339455Endoscope, accessories, narrow band spectrum

Maude Adverse Events

EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-31
EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-30
EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-30
EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-30
EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-27
EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-03-11
VISERA ELITE XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-06
EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-02-02
VISERA ELITE XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-28
VISERA ELITE XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-17
EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-16
EVIS EXERA III XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2020-01-10
OLYMPUS GIF-H190 GASTROSCOPEOLYMPUS SURGICAL TECHNOLOGIES AMERICA2019-06-18
OLYMPUSOLYMPUS MEDICAL SYSTEMS CORP.2019-03-22
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-03-08
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-02-08
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-01-31
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2019-01-16
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-12-20
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-11-19
URETERO-RENO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-10-31
OLYMPUS ERCP SCOPEOLYMPUS MEDICAL SYSTEM CORPORATION2018-10-25
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-10-04
VIDEOSCOPE "CYF-V2", EUROPEAN VERSIONOLYMPUS MEDICAL SYSTEMS CORP.2018-09-14
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-06-27
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-06-27
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-06-25
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-05-24
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-05-24
MAJ-1154 SCOPE CABLE CV-260OLYMPUS MEDICAL SYSTEMS CORP.2018-04-26
UNKNOWNOLYMPUS MEDICAL SYSTEM CORPORATION2018-04-23
EVIS EXERA II DUODENOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-04-11
ENDOSCOPE MODEL 160OLYMPUS MEDICAL SYSTEMS CORP.2018-04-10
VIDEOSCOPE "CYF-VA2", WITH SUCTION, EUROPEAN VERSIONOLYMPUS MEDICAL SYSTEMS CORP.2018-04-04
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-02-08
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-02-06
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-02-06
VISERA CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-02-06
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2018-01-15
CYSTO-NEPHRO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-12-26
ENDOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-12-21
UNKNOWNUNKNOWN2017-12-18
UNKNOWNUNKNOWN2017-12-18
UNKNOWNOLYMPUS MEDICAL SYSTEMS2017-12-05
VISERA PRO XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.2017-11-29
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-11-09
EVIS GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-11-09
EVIS LUCERA GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.2017-11-09
OLYMPUS MEDICAL SYSTEMS CORP.2017-11-08
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