Cleared Traditional

K112680 - EVIS EXERA III VIDEO SYSTEM

K112680 is the FDA 510(k) clearance for EVIS EXERA III VIDEO SYSTEM by Olympus Medical Systems Corporation. It is a Class 2 Gastroenterology & Urology device (product code FDF) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K112680 · Olympus Medical Systems Corporation · Gastroenterology & Urology device
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Feb 2012
Decision
155d
Days
Class 2
Risk

K112680 is an FDA 510(k) clearance for the EVIS EXERA III VIDEO SYSTEM. Classified as Colonoscope And Accessories, Flexible/rigid (product code FDF), Class II - Special Controls.

Submitted by Olympus Medical Systems Corporation (Center Valley, US). The FDA issued a Cleared decision on February 16, 2012 after a review of 155 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Olympus Medical Systems Corporation devices

Submission Details

510(k) Number K112680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2011
Decision Date February 16, 2012
Days to Decision 155 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
25d slower than avg
Panel avg: 130d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FDF Colonoscope And Accessories, Flexible/rigid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Examine Or Perform Procedures In The Colon Or Rectum 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 - FDF Colonoscope And Accessories, Flexible/rigid

All 58
Devices cleared under the same product code (FDF) and FDA review panel - the closest regulatory comparables to K112680.
Oracle EUS Balloon
K163492 · United States Endoscopy Group, Inc. · Jan 2017
EVIS EXERA III VIDEO SYSTEM
K131780 · Olympus Medical Systems Corp. · Aug 2013
V1 SYSTEM
K111756 · Olympus Medical Systems Corp. · Mar 2012
EUS BALLOON
K111028 · United States Endoscopy Group, Inc. · Nov 2011
UPD-Y0003
K103312 · Olympus Medical Systems Corporation · May 2011
OLYMPUS CF TYPE Y0023-L, Y0023I
K101053 · Olympus Medical Systems Corporation · Jul 2010