NWB — Endoscope, Accessories, Narrow Band Spectrum Class II
FDA product code NWB covers "Endoscope, Accessories, Narrow Band Spectrum", a Class II medical device regulated under 21 CFR 876.1500. Submissions are reviewed by the Gastroenterology, Urology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NWB
- Device Class
- Class II
- Regulation Number
- 876.1500
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K222020 | sonoscape medical | HD-550 Video Endoscope System | September 8, 2022 |
| K211882 | sonoscape medical | HD-550 Video Endoscope System | April 1, 2022 |
| K173921 | sonoscape medical | HD-500 Video Endoscope System | September 5, 2018 |
| K133538 | olympus corporation of the americas | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCO | August 7, 2014 |
| K100584 | olympus medical systems corporation | EVIS EXERAII 180 SYSTEM | July 2, 2010 |
| K090980 | olympus winter and ibe | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L | June 29, 2009 |
| K072957 | olympus medical systems corporation | EVIS EXERA II 180 SYSTEM | March 18, 2008 |
| K062049 | olympus medical systems corporation | EVIS EXERA II 180 SYSTEM | September 22, 2006 |
| K051645 | olympus medical systems corporation | EVIS EXERA 160A SYSTEM | October 13, 2005 |