Cleared Special

AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM

K191559 · United States Endoscopy Group, Inc. · Gastroenterology & Urology
Aug 2019
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K191559 is an FDA 510(k) clearance for the AquaShield System CO2, AquaShield System CO2-PENTAX, 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 August 1, 2019, 49 days after receiving the submission on June 13, 2019. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K191559 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2019
Decision Date August 01, 2019
Days to Decision 49 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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