NWB
9 FDA 510(k) clearances · Product code
122 daysmedian time to decision
284 days90th percentile
9clearances measured
FDA profile
- Official device name
- Endoscope, Accessories, Narrow Band Spectrum
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- FDA 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.
- Adverse events (MAUDE)
- 2021: 1,453 · 2022: 1,828 · 2023: 2,180 · 2024: 2,649 · 2025: 2,889 · 2026: 1,973
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HD-550 Video Endoscope System (K222020) | Sonoscape Medical Corp. | 2022-09-08 |
| HD-550 Video Endoscope System (K211882) | Sonoscape Medical Corp. | 2022-04-01 |
| HD-500 Video Endoscope System (K173921) | Sonoscape Medical Corp. | 2018-09-05 |
| VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE (K133538) | Olympus Corporation of the Americas | 2014-08-07 |
| EVIS EXERAII 180 SYSTEM (K100584) | Olympus Medical Systems Corporation | 2010-07-02 |
| HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980) | Olympus Winter & Ibe GmbH | 2009-06-29 |
| EVIS EXERA II 180 SYSTEM (K072957) | Olympus Medical Systems Corporation | 2008-03-18 |
| EVIS EXERA II 180 SYSTEM (K062049) | Olympus Medical Systems Corporation | 2006-09-22 |
| EVIS EXERA 160A SYSTEM (K051645) | Olympus Medical Systems Corporation | 2005-10-13 |
Track NWB automatically
Every clearance here is in the API, with alerts when new ones post.