FDA product code NWB: Endoscope, Accessories, Narrow Band Spectrum
NWB is the FDA product code for endoscope, accessories, narrow band spectrum. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under NWB, 2 in the last five years, from 4 different applicants. The average 510(k) review took 155 days (median 122). FDA has posted 19 recalls for NWB devices, 15 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Endoscope, Accessories, Narrow Band Spectrum |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for NWB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 253 |
| 2022 | 2 | 173 |
Compare with all 510(k) review times · Search every NWB clearance
Top NWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Medical Systems Corporation | 4 | 2010-07-02 |
| Sonoscape Medical Corp. | 3 | 2022-09-08 |
| Olympus Corporation of the Americas | 1 | 2014-08-07 |
| Olympus Winter & Ibe GmbH | 1 | 2009-06-29 |
Most recent NWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222020 | Sonoscape Medical Corp. | HD-550 Video Endoscope System | 2022-09-08 | 62 |
| K211882 | Sonoscape Medical Corp. | HD-550 Video Endoscope System | 2022-04-01 | 284 |
| K173921 | Sonoscape Medical Corp. | HD-500 Video Endoscope System | 2018-09-05 | 253 |
| K133538 | Olympus Corporation of the Americas | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE | 2014-08-07 | 262 |
| K100584 | Olympus Medical Systems Corporation | EVIS EXERAII 180 SYSTEM | 2010-07-02 | 122 |
Recalls for NWB devices
19 product recalls in 8 recall events; 15 initiated in the last five years and 15 still open. Most recent: 2025-05-05.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2022 | 2 |
| 2023 | 5 |
| 2024 | 7 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code NWB?
NWB is the FDA product code for endoscope, accessories, narrow band spectrum. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NWB?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
How long does a 510(k) take for product code NWB?
Across 9 cleared submissions the average was 155 days from receipt to decision (median 122).
Which companies have the most NWB clearances?
Olympus Medical Systems Corporation (4); Sonoscape Medical Corp. (3); Olympus Corporation of the Americas (1); Olympus Winter & Ibe GmbH (1).
Have NWB devices been recalled?
Yes: 19 product recalls across 8 recall events; the most recent began 2025-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NWB
- Run a recall and safety report across every NWB manufacturer
- Watch product code NWB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times