Cleared Special

EndoChoice Water Bottle Cap Irrigation System

K161482 · Endochoice, Inc. · Gastroenterology & Urology
Jun 2016
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K161482 is an FDA 510(k) clearance for the EndoChoice Water Bottle Cap Irrigation System, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on June 27, 2016, 27 days after receiving the submission on May 31, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K161482 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code FEQ — Pump, Air, Non-manual, For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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