Cleared Traditional

K134026 - ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT (FDA 510(k) Clearance)

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

K134026 · Olympus Medical Systems Corp. · Gastroenterology & Urology device
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Mar 2014
Decision
67d
Days
Class 2
Risk

K134026 is an FDA 510(k) clearance for the ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT. Classified as Spatial Imaging For Display Of Endoscope Position (product code PGU), Class II - Special Controls.

Submitted by Olympus Medical Systems Corp. (Center Valley, US). The FDA issued a Cleared decision on March 7, 2014 after a review of 67 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 Corp. devices

Submission Details

510(k) Number K134026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date March 07, 2014
Days to Decision 67 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
63d faster than avg
Panel avg: 130d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGU Spatial Imaging For Display Of Endoscope Position
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Detect And Display The Shape Of An Inserted Endoscope.
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.