Cleared Special

Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand

K182164 · Ecolab, Inc. · Gastroenterology & Urology

Mar 2019

Decision

231d

Days

Class 2

Risk

About This 510(k) Submission

K182164 is an FDA 510(k) clearance for the Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand, a System, Water Purification, General Medical Use (Class II — Special Controls, product code NHV), submitted by Ecolab, Inc. (St Paul, US). The FDA issued a Cleared decision on March 29, 2019, 231 days after receiving the submission on August 10, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number	K182164 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 10, 2018
Decision Date	March 29, 2019
Days to Decision	231 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	NHV — System, Water Purification, General Medical Use
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5665
Definition	The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing.