Data / Medical devices / Endoscope, Accessories, Narrow Band Spectrum
Endoscope, Accessories, Narrow Band Spectrum (NWB): 18 FDA-registered makers in 5 countries
18 establishments in 5 countries are registered with the FDA to make Endoscope, Accessories, Narrow Band Spectrum (product code NWB, Class 2, 21 CFR 876.1500). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 9 510(k) clearances under this code, the latest on September 8, 2022, and lists 8 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- NWB
- Device class
- 2
- Regulation
- 876.1500
- Medical specialty
- Gastroenterology, Urology
Makers by country
| Country | Makers |
|---|---|
| Japan | 10 |
| China | 4 |
| United States | 2 |
| Germany | 1 |
| Thailand | 1 |
Makers of Endoscope, Accessories, Narrow Band Spectrum
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Olympus Medical Systems Corp. | HACHIOJI-SHI Tokyo, Japan | Specification developer | 5 | August 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Shirakawa Olympus Co., Ltd. | NISHISHIRAKAWA-GUN Fukushima, Japan | Manufacturer | 4 | August 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Aizu Olympus Co., Ltd. | AIZUWAKAMATSU-SHI Fukushima, Japan | Manufacturer | 2 | July 2, 2010 | 0 | 1 | 0 | api.fda.gov |
| Olympus Winter & Ibe GMBH | Hamburg, Germany | Manufacturer | 1 | June 29, 2009 | 0 | 0 | 0 | api.fda.gov |
| Sonoscape Medical Corp. | Shenzhen Guangdong, China | Manufacturer | 1 | September 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sonoscape Medical Corp. | SHENZHEN Guangdong, China | Manufacturer | 1 | September 8, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | Shirakawa Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJI SYSTEMS CORPORATION, Shirakawa Plant | Nishi Shirakawa Gun Fukushima, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fujifilm Corporation | ASHIGARAKAMI-GUN Kanagawa, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Corporation Medical Systems Research & Development Center Kaisei | Ashigarakami-Gun Kanagawa, Japan | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office | HANAMAKI-SHI Iwate, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| FUJIFILM Healthcare Manufacturing Corporation Sano Office | Sano City Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Life Science Logistics, LLC | Brownsburg, IN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| OLYMPUS MEDICAL SYSTEMS CORP. Hinode Plant | NISHITAMA-GUN Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omec Thai Co.,ltd. | Bang Bo District Samut Prakan, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Qingdao O-Mec Medical Technology Co., Ltd. | Qingdao Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scivita Medical Technology Co., Ltd. | suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Endoscopy | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 8, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.