Cleared Special

AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm

K182258 · United States Endoscopy Group, Inc. · Gastroenterology & Urology
Sep 2018
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K182258 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 September 21, 2018, 31 days after receiving the submission on August 21, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K182258 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2018
Decision Date September 21, 2018
Days to Decision 31 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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