Cleared Special

AquaShield system CO2, AquaShield system-PENTAX (K153362) - FDA 510(k) Clearance

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

K153362 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Dec 2015
Decision
26d
Days
Class 2
Risk

K153362 is an FDA 510(k) clearance for the AquaShield system CO2, AquaShield system-PENTAX. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on December 16, 2015 after a review of 26 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. devices

Submission Details

510(k) Number K153362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2015
Decision Date December 16, 2015
Days to Decision 26 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FEQ Pump, Air, Non-manual, For Endoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
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 - FEQ Pump, Air, Non-manual, For Endoscope

All 20
Devices cleared under the same product code (FEQ) and FDA review panel - the closest regulatory comparables to K153362.
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AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
K191559 · United States Endoscopy Group, Inc. · Aug 2019
AquaShield System CO2
K182258 · United States Endoscopy Group, Inc. · Sep 2018
AquaShield System CO2- Fujifilm
K173650 · United States Endoscopy Group, Inc. · Jan 2018