Cleared Special

K041494 - OLYMPUS INTEGRATED ENDOSURGERY SYSTEM E...

K041494 is an FDA 510(k) clearance for OLYMPUS INTEGRATED ENDOSURGERY SYSTEM E..., manufactured by Olympus Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FET cleared through the Special 510(k) pathway after a 27-day FDA review.

K041494 · Olympus Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
27d
Days
Class 2
Risk

K041494 is an FDA 510(k) clearance for the OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY.... Classified as Endoscopic Video Imaging System/component, Gastroenterology-urology (product code FET), Class II - Special Controls.

Submitted by Olympus Corporation (Melville, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus Corporation devices

FDA 510(k) Submission Details - K041494

510(k) Number K041494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2004
Decision Date July 01, 2004
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 130d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

FET Device Classification - Class 2, Special Controls

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

All 58
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