Cleared Special

K123317 - EVIS EXERA III GASTROINTESTINAL VIDEOSC...

K123317 is the FDA 510(k) clearance for EVIS EXERA III GASTROINTESTINAL VIDEOSC... by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDS) cleared through the Special 510(k) pathway after a 47-day FDA review.

K123317 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Dec 2012
Decision
47d
Days
Class 2
Risk

K123317 is an FDA 510(k) clearance for the EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIXP190N. Classified as Gastroscope And Accessories, Flexible/rigid (product code FDS), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on December 11, 2012 after a review of 47 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 Medical Systems Corporation devices

Submission Details

510(k) Number K123317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2012
Decision Date December 11, 2012
Days to Decision 47 days
Submission Type Special
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
83d faster than avg
Panel avg: 130d · This submission: 47d
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 55
Devices cleared under the same product code (FDS) and FDA review panel - the closest regulatory comparables to K123317.
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OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
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