Cleared Traditional

HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L (K090980) - FDA 510(k) Clearance

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

K090980 · Olympus Winter & Ibe GmbH · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
83d
Days
Class 2
Risk

K090980 is an FDA 510(k) clearance for the HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L. Classified as Endoscope, Accessories, Narrow Band Spectrum (product code NWB), Class II - Special Controls.

Submitted by Olympus Winter & Ibe GmbH (Center Valley, US). The FDA issued a Cleared decision on June 29, 2009 after a review of 83 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 Winter & Ibe GmbH devices

Submission Details

510(k) Number K090980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2009
Decision Date June 29, 2009
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
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.