Cleared Traditional

ENDOSCOPIC LIGHT SOURCE LS-3000X (K032545) - FDA 510(k) Clearance

Also marketed or referenced as:
LS-1800XG/MED LIGHT X 180 LS-2500H/MED LIGHT H 250

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

K032545 · Mgb Endoskopische Gerate GmbH (Berlin) · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
15d
Days
Class 2
Risk

K032545 is an FDA 510(k) clearance for the ENDOSCOPIC LIGHT SOURCE LS-3000X. Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Mgb Endoskopische Gerate GmbH (Berlin) (Berlin, DE). The FDA issued a Cleared decision on September 2, 2003 after a review of 15 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 Mgb Endoskopische Gerate GmbH (Berlin) devices

Submission Details

510(k) Number K032545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2003
Decision Date September 02, 2003
Days to Decision 15 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 130d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FET Endoscopic Video Imaging System/component, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Allow For Visualization Of Body Cavities Through An Endoscope By Projecting Images To A Monitor.
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 - FET Endoscopic Video Imaging System/component, Gastroenterology-urology

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