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Product codes
NWB
Product code NWB
Device name
Endoscope, Accessories, Narrow Band Spectrum
Medical specialty
Gastroenterology, Urology
Device class
2
Regulation number
876.1500
Review panel
GU
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
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.
Source
FDA openFDA device classification dataset
Related 510(k) Records
#
510(k), Device, Applicant table
510(k)
Device
Applicant
Decision date
K222020
HD-550 Video Endoscope System
Sonoscape Medical Corp.
2022-09-08
K211882
HD-550 Video Endoscope System
Sonoscape Medical Corp.
2022-04-01
K173921
HD-500 Video Endoscope System
Sonoscape Medical Corp.
2018-09-05
K133538
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE
Olympus Corporation of the Americas
2014-08-07
K100584
EVIS EXERAII 180 SYSTEM
Olympus Medical Systems Corporation
2010-07-02
K090980
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
Olympus Winter & Ibe GmbH
2009-06-29
K072957
EVIS EXERA II 180 SYSTEM
Olympus Medical Systems Corporation
2008-03-18
K062049
EVIS EXERA II 180 SYSTEM
Olympus Medical Systems Corporation
2006-09-22
K051645
EVIS EXERA 160A SYSTEM
Olympus Medical Systems Corporation
2005-10-13
Related GUDID Devices
#
Primary DI, Brand, Company table
Primary DI
Brand
Company
Published
04547410513790
FUJIFILM
FUJIFILM CORPORATION
2025-05-31
07613327616682
SPY
STRYKER CORPORATION
2024-02-27
07613327616699
SPY
STRYKER CORPORATION
2024-02-27
07613327616705
SPY
STRYKER CORPORATION
2024-02-27
07613327616712
SPY
STRYKER CORPORATION
2024-02-27
07613327616729
SPY
STRYKER CORPORATION
2024-02-27
07613327616743
SPY
STRYKER CORPORATION
2024-02-27
07613327608915
1788
STRYKER CORPORATION
2023-12-11
04547410446104
FUJIFILM
FUJIFILM CORPORATION
2021-09-29
04547410446081
FUJIFILM
FUJIFILM CORPORATION
2021-09-29
04042761083492
Olympus
OLYMPUS Winter & Ibe GmbH
2020-07-31
04042761083485
Olympus
OLYMPUS Winter & Ibe GmbH
2020-07-31
04547410384543
FUJIFILM
FUJIFILM CORPORATION
2020-07-20
04547410420685
FUJIFILM
FUJIFILM CORPORATION
2020-03-15
B747EAI0788
Endoch
Endoch Inc
2019-10-01
B747EAI0784
Endoch
Endoch Inc
2019-10-01
B747EAI0787
Endoch
Endoch Inc
2019-10-01
B747EAI0785
Endoch
Endoch Inc
2019-10-01
B747EAI0628
Endoch
Endoch Inc
2019-10-01
B747EAI0535
Endoch
Endoch Inc
2019-10-01
B747EAI0503
Endoch
Endoch Inc
2019-10-01
B747EAI0502
Endoch
Endoch Inc
2019-10-01
B747EAI0496
Endoch
Endoch Inc
2019-10-01
04547410337419
FUJIFILM
FUJIFILM CORPORATION
2017-05-23
04547410337730
FUJIFILM
FUJIFILM CORPORATION
2017-05-23
14953170154291
SINGLE USE BIOPSY VALVE
OLYMPUS MEDICAL SYSTEMS CORP.
2016-09-21
14953170152433
SINGLE USE BIOPSY VALVE
OLYMPUS MEDICAL SYSTEMS CORP.
2016-09-21
14953170152426
SINGLE USE SUCTION VALVE
OLYMPUS MEDICAL SYSTEMS CORP.
2016-09-21
04953170022821
VIDEOSCOPE CABLE HOLDER
OLYMPUS MEDICAL SYSTEMS CORP.
2016-09-21
04953170022852
SPARE FUSE
OLYMPUS MEDICAL SYSTEMS CORP.
2016-09-21