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.

Single USE Distal Cover · Endoscope, Accessories, Narrow Band Spectrum → Gastroenterology & Urology

Name: Single USE Distal Cover
Brand: Single USE Distal Cover

3manufacturers in China registered for this device type

1catalogue number

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 Single USE Distal Cover
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	2020-01-27
Record revised	2026-02-17 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date
Packaging	Pack of 20, pack of 60

Catalogue Numbers

Catalogue numbers for Single USE Distal Cover
Catalogue number	Size	Status
MAJ-2315		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
Foot Switch	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

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Single USE Distal Cover
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Olympus Corporation of the Americas	UDI-DI	2023-04-18	Class II	Device Design	The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent r	309278 pieces

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.

Single USE Distal Cover