Cleared Special

AquaShield System CO2- Fujifilm

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

About This 510(k) Submission

K173650 is an FDA 510(k) clearance for the AquaShield System CO2- Fujifilm, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on January 5, 2018, 38 days after receiving the submission on November 28, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K173650 FDA.gov
FDA Decision Cleared 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

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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