Cleared Special

K161482 - EndoChoice Water Bottle Cap Irrigation System

K161482 is an FDA 510(k) clearance for EndoChoice Water Bottle Cap Irrigation ..., manufactured by Endochoice, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FEQ cleared through the Special 510(k) pathway after a 27-day FDA review.

K161482 · Endochoice, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
27d
Days
Class 2
Risk

K161482 is an FDA 510(k) clearance for the EndoChoice Water Bottle Cap Irrigation System. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 27, 2016 after a review of 27 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 - K161482

510(k) Number K161482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2016
Decision Date June 27, 2016
Days to Decision 27 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 131d · This submission: 27d
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 K161482.
AquaShield System CO2- Fujifilm
K173650 · United States Endoscopy Group, Inc. · Jan 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 System
K153588 · Endochoice, Inc. · Feb 2016
AquaShield system CO2, AquaShield system-PENTAX
K153362 · United States Endoscopy Group, Inc. · Dec 2015
ENDOCHOICE WATER BOTTLE CAP SYSTEM
K142155 · Endochoice, Inc. · Jan 2015