Cleared Special

Ultramatrix EUS Balloon (K180731) - FDA 510(k) Clearance

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

K180731 · United States Endoscopy Group, Inc. (Us Endoscopy) · Gastroenterology & Urology device
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Apr 2018
Decision
30d
Days
Class 2
Risk

K180731 is an FDA 510(k) clearance for the Ultramatrix EUS Balloon. Classified as Endoscopic Ultrasound System, Gastroenterology-urology (product code ODG), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Us Endoscopy) (Mentor, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 30 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 United States Endoscopy Group, Inc. (Us Endoscopy) devices

Submission Details

510(k) Number K180731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2018
Decision Date April 19, 2018
Days to Decision 30 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 130d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ODG Endoscopic Ultrasound System, Gastroenterology-urology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. 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 - ODG Endoscopic Ultrasound System, Gastroenterology-urology

All 41
Devices cleared under the same product code (ODG) and FDA review panel - the closest regulatory comparables to K180731.
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