NOVAPROBE LED LIGHT SOURCE— 510(k) K131226

Substantially Equivalent

Novaprobe Incorporated

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

Clearance details

Applicant: Novaprobe Incorporated
Product code: Code FCW
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 ↗

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.