510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NTNClass II

Led Light Source

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

NTN is the FDA product code for Led Light Source, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NTN
Device name
Led Light Source
FDA definition
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code NTN

By decision year
9 clearances under product code NTN with a decision year between 2009 and 2015, 2009 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NTN by decision year
YearClearances
20092
20101
20111
20122
20131
20141
20151

Applicants with the most clearances

Product code NTN
Applicants holding the most 510(k) clearances under product code NTN
ApplicantClearances
Olympus Winter & Ibe GmbH2
Fiberoptics Technology, Inc.1
Maquet SAS1
Olympus Medical Systems Corp.1
Optim LLC1
Quest Medical Imaging1
Schoelly Imaging, Inc.1
Sopro1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 76 companies shown, in name order