Cleared Special

K220395 - EndoGator Endoscopy Irrigation Tubing

K220395 is an FDA 510(k) clearance for EndoGator Endoscopy Irrigation Tubing, manufactured by STERIS Corporation. The device is a Class 2 Gastroenterology & Urology device with product code FEQ cleared through the Special 510(k) pathway after a 28-day FDA review.

K220395 · STERIS Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2022
Decision
28d
Days
Class 2
Risk

K220395 is an FDA 510(k) clearance for the EndoGator Endoscopy Irrigation Tubing. Classified as Pump, Air, Non-manual, For Endoscope (product code FEQ), Class II - Special Controls.

Submitted by STERIS Corporation (Mentor, US). The FDA issued a Cleared decision on March 11, 2022 after a review of 28 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 - K220395

510(k) Number K220395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2022
Decision Date March 11, 2022
Days to Decision 28 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
103d faster than avg
Panel avg: 131d · This submission: 28d
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 K220395.
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
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
K220395 · EndoGator Endoscopy Irrigation Tubing
Download PDF FDA Summary STERIS Corporation