NWB · Class II · 21 CFR 876.1500

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 Sonoscape Medical Corp..

9
Total
9
Cleared
155d
Avg days
2005
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Endoscope, Accessories, Narrow Band Spectrum Devices (Product Code NWB)

9 devices
1–9 of 9
Cleared Sep 08, 2022
HD-550 Video Endoscope System
K222020
Sonoscape Medical Corp.
Gastroenterology & Urology · 62d
Cleared Apr 01, 2022
HD-550 Video Endoscope System
K211882
Sonoscape Medical Corp.
Gastroenterology & Urology · 284d

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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NWB devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →