NOVAPROBE LED LIGHT SOURCE— 510(k) K131226

Name: FDA 510(k) clearance K131226
Creator: U.S. Food and Drug Administration
Published: 2014-07-24

Substantially Equivalent

Novaprobe Incorporated

FDA 510(k) clearance K131226 for NOVAPROBE LED LIGHT SOURCE, Substantially Equivalent on 2014-07-24. Applicant: Novaprobe Incorporated. Device class: 2.

Clearance details

Applicant: Novaprobe Incorporated
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2013-04-30
Decision date: 2014-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lansdale, PA, US

Download summary PDF View on FDA.gov ↗

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K093792 — LED LIGHT SOURCE2010-03-18
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Adverse events under product code FCW

product code FCW

Malfunction: 912
Other: 1
Total: 913

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.