What is FDA product code NWB?

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.

Foot Switch · Endoscope, Accessories, Narrow Band Spectrum → Gastroenterology & Urology

Name: Foot Switch
Brand: Foot Switch

3manufacturers in China registered for this device type

3catalogue numbers in this listing

4510(k) clearances naming this product code

Who Else Makes It

Concentrated in Jiangsu (1), Guangdong (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NWB
Manufacturer	City	Province	Registered as	Device types
Qingdao O-MEC Medical Technology Co., Ltd.	Qingdao	Shandong	Contract manufacturer	6
Scivita Medical Technology Co., Ltd.	Suzhou	Jiangsu	Manufacturer	19
Sonoscape Medical Corp.	Shenzhen	Guangdong	Manufacturer	7

Record

Regulatory record for Foot Switch
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	NWB
Device type	Endoscope, Accessories, Narrow Band Spectrum
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
Record published	2016-09-21
Record revised	2023-01-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Foot Switch
Catalogue number	Size	Status
MAJ-574		In distribution
MAJ-1391		In distribution
MAJ-1805		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
SonoScape	Sonoscape Medical Corp.	10
Medisono	Medisono, LLC	10
Evis Exera II Colonovideoscope	Olympus Medical Systems Corp.	8
Rhino-Laryngo Videoscope	Olympus Medical Systems Corp.	7
Evis Exera II Gastrointestinal Videoscope	Olympus Medical Systems Corp.	7
Visera Cysto-Nephro Videoscope	Olympus Medical Systems Corp.	6
Uretero-Reno Videoscope	Olympus Medical Systems Corp.	4
Cysto-Nephro Videoscope	Olympus Medical Systems Corp.	4
Olympus	Olympus Winter & IBE Gmbh	4
Foot Holder	Olympus Medical Systems Corp.	3
Light source cable	Olympus Medical Systems Corp.	3
Evis Exera II Duodenovideoscope	Olympus Medical Systems Corp.	3

Showing 12 of 66. All products under Endoscope, Accessories, Narrow Band Spectrum

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K100584	2010-07-02
K072957	2008-03-18
K062049	2006-09-22
K051645	2005-10-13

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Foot Switch