Cleared Traditional

K903790 - ENDOSCOPIC LIGHT SOURCE 250 ENDO

K903790 is an FDA 510(k) clearance for ENDOSCOPIC LIGHT SOURCE 250 ENDO, manufactured by Orlux Engineering and Instrumentation. The device is a Class 2 Gastroenterology & Urology device with product code FCW cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K903790 · Orlux Engineering and Instrumentation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
109d
Days
Class 2
Risk

K903790 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE 250 ENDO. Classified as Light Source, Fiberoptic, Routine (product code FCW), Class II - Special Controls.

Submitted by Orlux Engineering and Instrumentation (Brampton, Ontario, CA). The FDA issued a Cleared decision on December 7, 1990 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1500 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Orlux Engineering and Instrumentation devices

FDA 510(k) Submission Details - K903790

510(k) Number K903790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1990
Decision Date December 07, 1990
Days to Decision 109 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 130d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FCW Device Classification - Class 2, Special Controls

Product Code FCW Light Source, Fiberoptic, Routine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FCW Light Source, Fiberoptic, Routine

All 13
Devices cleared under the same product code (FCW) and FDA review panel - the closest regulatory comparables to K903790.
WELCH ALLYN HI - LUX ILLUMINATOR
K951647 · Welch Allyn, Inc. · May 1995
AUTO SUTURE DISPOSABLE LIGHT CABLE
K934531 · United States Surgical, A Division of Tyco Healthc · May 1994
STORZ S6000 LIGHT SOURCE
K905376 · Storz Instrument Co. · Jan 1991
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K852951 · Welch Allyn, Inc. · Aug 1985
PEDIATRIC ILLUMINATING URETERAL
K832807 · Van-Tec, Inc. · Oct 1983
PENTAX LH-150F LIGHT SOURCE
K771739 · Pilling Co. · Sep 1977