FDA Product Code NWB: Endoscope, Accessories, Narrow Band Spectrum
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.
Leading manufacturers include Olympus Medical Systems Corporation, Sonoscape Medical Corp. and Olympus Winter & Ibe GmbH.
9
Total
9
Cleared
155d
Avg days
2005
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Endoscope, Accessories, Narrow Band Spectrum Devices (Product Code NWB)
9 devices
Cleared
Sep 08, 2022
HD-550 Video Endoscope System
Sonoscape Medical Corp.
Gastroenterology & Urology
62d
Cleared
Apr 01, 2022
HD-550 Video Endoscope System
Sonoscape Medical Corp.
Gastroenterology & Urology
284d
Cleared
Sep 05, 2018
HD-500 Video Endoscope System
Sonoscape Medical Corp.
Gastroenterology & Urology
253d
Cleared
Aug 07, 2014
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE
Olympus Corporation of the Americas
Gastroenterology & Urology
262d
Cleared
Jul 02, 2010
EVIS EXERAII 180 SYSTEM
Olympus Medical Systems Corporation
Gastroenterology & Urology
122d
Cleared
Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
Olympus Winter & Ibe GmbH
Gastroenterology & Urology
83d
Cleared
Mar 18, 2008
EVIS EXERA II 180 SYSTEM
Olympus Medical Systems Corporation
Gastroenterology & Urology
151d
Cleared
Sep 22, 2006
EVIS EXERA II 180 SYSTEM
Olympus Medical Systems Corporation
Gastroenterology & Urology
64d
Cleared
Oct 13, 2005
EVIS EXERA 160A SYSTEM
Olympus Medical Systems Corporation
Gastroenterology & Urology
115d
About Product Code NWB - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code NWB since 2005, with 9 receiving FDA clearance (average review time: 155 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.