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.

Cysto-Nephro Videoscope · Endoscope, Accessories, Narrow Band Spectrum → Gastroenterology & Urology

Name: Cysto-Nephro Videoscope
Brand: Cysto-Nephro Videoscope

3manufacturers in China registered for this device type

4catalogue 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 Cysto-Nephro Videoscope
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	2024-06-19 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Sterilisation	High-level Disinfectant, Ethylene Oxide
Prescription	Prescription only
Label carries	manufacturing date, serial number
Distribution end date	2024-01-11

Catalogue Numbers

Catalogue numbers for Cysto-Nephro Videoscope
Catalogue number	Size	Status
OLYMPUS CYF-VHR		Withdrawn
OLYMPUS CYF-VHA		Withdrawn
OLYMPUS CYF-VH		Withdrawn
OLYMPUS CYF-VHA		Withdrawn

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
Olympus	Olympus Winter & IBE Gmbh	4
Foot Holder	Olympus Medical Systems Corp.	3
Light source cable	Olympus Medical Systems Corp.	3
Foot Switch	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

Recalls Naming This Product

2 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Cysto-Nephro Videoscope
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Shirakawa Olympus Co., Ltd.	UDI-DI	2023-12-04	Class II	Under Investigation by firm	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.	4780 US; 10448 OUS
Shirakawa Olympus Co., Ltd.	UDI-DI	2023-12-04	Class II	Under Investigation by firm	Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.	1547 US; 2772 OUS

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.

Cysto-Nephro Videoscope