Cleared Traditional

ENDOSCOPIC LIGHT SOURCE XL180/L3 (K023468) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023468 · World of Medicine Lemke GmbH · Gastroenterology & Urology device
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Jan 2003
Decision
90d
Days
Class 2
Risk

K023468 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE XL180/L3. Classified as Light Source, Endoscope, Xenon Arc (product code GCT), Class II - Special Controls.

Submitted by World of Medicine Lemke GmbH (Cambridge, US). The FDA issued a Cleared decision on January 14, 2003 after a review of 90 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 World of Medicine Lemke GmbH devices

Submission Details

510(k) Number K023468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2002
Decision Date January 14, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GCT Light Source, Endoscope, Xenon Arc
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 - GCT Light Source, Endoscope, Xenon Arc

All 46
Devices cleared under the same product code (GCT) and FDA review panel - the closest regulatory comparables to K023468.
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K954561 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
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K934559 · KARL STORZ Endoscopy-America, Inc. · Apr 1994