510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
NWBClass II

Endoscope, Accessories, Narrow Band Spectrum

21 CFR 876.1500 / Gastroenterology, Urology
FDA source (opens on fda.gov)

NWB is the FDA product code for Endoscope, Accessories, Narrow Band Spectrum, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
NWB
Device name
Endoscope, Accessories, Narrow Band Spectrum
FDA 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.
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
19

Clearances, product code NWB

By decision year
9 clearances under product code NWB with a decision year between 2005 and 2022, 2022 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NWB by decision year
YearClearances
20051
20061
20081
20091
20101
20141
20181
20222

Applicants with the most clearances

Product code NWB
Applicants holding the most 510(k) clearances under product code NWB
ApplicantClearances
Olympus Medical Systems Corp.4
Sonoscape Medical Corp.3
OLYMPUS Corporation of the Americas1
Olympus Winter & Ibe GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 33 companies shown, in name order