Cleared Traditional

ENDOSCOPIC LIGHT SOURCE XL202/L3 (K020889) - FDA 510(k) Clearance

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

K020889 · World of Medicine Lemke GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
78d
Days
Class 2
Risk

K020889 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE XL202/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 June 5, 2002 after a review of 78 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all World of Medicine Lemke GmbH devices

Submission Details

510(k) Number K020889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2002
Decision Date June 05, 2002
Days to Decision 78 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
52d faster than avg
Panel avg: 130d · This submission: 78d
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 K020889.
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925 · KARL STORZ Endoscopy-America, Inc. · Dec 2008
KSEA MEDI PACK
K022490 · KARL STORZ Endoscopy-America, Inc. · Sep 2003
XENON NOPPVA
K954561 · KARL STORZ Endoscopy-America, Inc. · Oct 1995
KARL STORZ XENON LIGHT SOURCE MODEL 201320-20
K934559 · KARL STORZ Endoscopy-America, Inc. · Apr 1994