Cleared Traditional

K062049 - EVIS EXERA II 180 SYSTEM

K062049 is the FDA 510(k) clearance for EVIS EXERA II 180 SYSTEM by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code NWB) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K062049 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Sep 2006
Decision
64d
Days
Class 2
Risk

K062049 is an FDA 510(k) clearance for the EVIS EXERA II 180 SYSTEM. Classified as Endoscope, Accessories, Narrow Band Spectrum (product code NWB), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on September 22, 2006 after a review of 64 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 Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K062049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2006
Decision Date September 22, 2006
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NWB Endoscope, Accessories, Narrow Band Spectrum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Alternative Mode Of Visualization Using Narrow Bands From The Visible Spectrum For Illumination And Indicated For Endoscopy And Endoscopic Surgery Of The Upper And Lower Diagestive Tract And Urinary Tract.
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 - NWB Endoscope, Accessories, Narrow Band Spectrum

All 7
Devices cleared under the same product code (NWB) and FDA review panel - the closest regulatory comparables to K062049.
EVIS EXERAII 180 SYSTEM
K100584 · Olympus Medical Systems Corporation · Jul 2010
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
K090980 · Olympus Winter & Ibe GmbH · Jun 2009
EVIS EXERA II 180 SYSTEM
K072957 · Olympus Medical Systems Corporation · Mar 2008
EVIS EXERA 160A SYSTEM
K051645 · Olympus Medical Systems Corporation · Oct 2005