ENDOSCOPIC LIGHT SOURCE 250 ENDO— 510(k) K903790

Name: FDA 510(k) clearance K903790
Creator: U.S. Food and Drug Administration
Published: 1990-12-07

Substantially Equivalent

Orlux Engineering and Instrumentation

FDA 510(k) clearance K903790 for ENDOSCOPIC LIGHT SOURCE 250 ENDO, Substantially Equivalent on 1990-12-07. Applicant: Orlux Engineering and Instrumentation. Device class: 2.

Clearance details

Applicant: Orlux Engineering and Instrumentation
Product code: Code FCW
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1990-08-20
Decision date: 1990-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brampton, Ontario, CA

Download summary PDF View on FDA.gov ↗

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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.