510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903790Substantially Equivalent

Endoscopic Light Source 250 Endo

Orlux Engineering and Instrumentation, Brampton, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903790 is the FDA 510(k) clearance record for ENDOSCOPIC LIGHT SOURCE 250 ENDO, a class II device, cleared for Orlux Engineering and Instrumentation on under FDA product code FCW (Light Source, Fiberoptic, Routine). FDA records list 2 510(k) clearances for Orlux Engineering and Instrumentation, from to . As of , FDA records show no recalls naming K903790.

Clearance record

Decision date
Received
(109 days to decision)
Product code
FCW Light Source, Fiberoptic, Routine
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Orlux Engineering and Instrumentation 18 Strathearn Ave., Brampton, Ontario, CA
Third party review
No

Clearances, product code FCW

Trailing 12 months

FDA records hold no clearances under product code FCW in the trailing twelve months.

FDA records show no clearances under product code FCW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FCW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260