Cleared Special

K173650 - AquaShield System CO2- Fujifilm

K173650 is an FDA 510(k) clearance for AquaShield System CO2- Fujifilm, manufactured by United States 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 38-day FDA review.

K173650 · United States Endoscopy Group, Inc. · Gastroenterology & Urology device
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Jan 2018
Decision
38d
Days
Class 2
Risk

K173650 is an FDA 510(k) clearance for the AquaShield System CO2- Fujifilm. 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 January 5, 2018 after a review of 38 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.

FDA 510(k) Submission Details - K173650

510(k) Number K173650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2017
Decision Date January 05, 2018
Days to Decision 38 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
93d faster than avg
Panel avg: 131d · This submission: 38d
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 20
Devices cleared under the same product code (FEQ) and FDA review panel - the closest regulatory comparables to K173650.
EndoGator Endoscopy Irrigation Tubing
K220395 · STERIS Corporation · Mar 2022
AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM
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AquaShield System CO2
K182258 · United States Endoscopy Group, Inc. · Sep 2018
AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON
K163424 · United State Endoscopy Group, Inc. · Jan 2017
Erbe’s CO2 Tubing/Cap Sets
K162152 · Erbe USA, Inc. · Aug 2016
EndoChoice Water Bottle Cap Irrigation System
K161482 · Endochoice, Inc. · Jun 2016
K173650 · AquaShield System CO2- Fujifilm
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