Cleared Special

K163424 - AquaShield System - PENTAX

K163424 is an FDA 510(k) clearance for AquaShield System - PENTAX, manufactured by United State Endoscopy Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEQ cleared through the Special 510(k) pathway after a 29-day FDA review.

K163424 · United State Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jan 2017
Decision
29d
Days
Class 2
Risk

K163424 is an FDA 510(k) clearance for the AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System.... Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by United State Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 4, 2017 after a review of 29 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 State Endoscopy Group, Inc. devices

FDA 510(k) Submission Details - K163424

510(k) Number K163424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2016
Decision Date January 04, 2017
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

FEQ Device Classification - Class 2, Special Controls

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 17
Devices cleared under the same product code (FEQ) and FDA review panel - the closest regulatory comparables to K163424.
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
Erbe’s CO2 Tubing/Cap Sets
K162152 · Erbe USA, Inc. · Aug 2016
EndoChoice Water Bottle Cap Irrigation System
K161482 · Endochoice, Inc. · Jun 2016
EndoChoice Water Bottle Cap System
K153588 · Endochoice, Inc. · Feb 2016