Cleared Special

K011151 - EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011151 · The Olympus Optical Co. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
29d
Days
Class 2
Risk

K011151 is an FDA 510(k) clearance for the EVIS EXERA GASTROINTESTINAL VIDEOSCOPE GIF-Q160Z. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by The Olympus Optical Co. (Melville, US). The FDA issued a Cleared decision on May 15, 2001 after a review of 29 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 The Olympus Optical Co. devices

Submission Details

510(k) Number K011151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2001
Decision Date May 15, 2001
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FDS Gastroscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Stomach. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - FDS Gastroscope And Accessories, Flexible/rigid

All 74
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