ENDOSCOPIC LIGHT SOURCE 250 ENDO— 510(k) K903790

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.

Clearance details

Applicant: Orlux Engineering and Instrumentation
Product code: Code FCW
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 ↗

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.