FDA product code NTN: Led Light Source
NTN is the FDA product code for led light source. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 9 510(k) submissions under NTN, from 8 different applicants. The average 510(k) review took 111 days (median 83).
Definition
Used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals
Classification
| Field | Value |
|---|---|
| Device name | Led Light Source |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NTN clearance
Top NTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Olympus Winter & Ibe GmbH | 2 | 2014-07-30 |
| Quest Medical Imaging | 1 | 2015-03-16 |
| Olympus Medical Systems Corp. | 1 | 2012-12-14 |
| Maquet S.A.S. | 1 | 2012-01-12 |
| Sopro | 1 | 2011-03-22 |
3 more applicants have NTN clearances. See the full list in Caduvo.
Most recent NTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K141164 | Quest Medical Imaging | ARTEMIS LIGHT ENGINE | 2015-03-16 | 315 |
| K133311 | Olympus Winter & Ibe GmbH | ENDOLED | 2014-07-30 | 275 |
| K130819 | Olympus Winter & Ibe GmbH | CLL- V1 LIGHT SOURCE | 2013-06-19 | 86 |
| K122831 | Olympus Medical Systems Corp. | VIDEO SYSTEM CENTER | 2012-12-14 | 88 |
| K113679 | Maquet S.A.S. | LUCEA LED SURGICAL LIGHT SYSTEM | 2012-01-12 | 29 |
Recalls for NTN devices
openFDA lists no recalls for product code NTN.
Frequently asked questions
What is FDA product code NTN?
NTN is the FDA product code for led light source. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is NTN?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NTN?
Across 9 cleared submissions the average was 111 days from receipt to decision (median 83).
Which companies have the most NTN clearances?
Olympus Winter & Ibe GmbH (2); Quest Medical Imaging (1); Olympus Medical Systems Corp. (1); Maquet S.A.S. (1); Sopro (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NTN
- Run a recall and safety report across every NTN manufacturer
- Watch product code NTN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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