Cleared Special

FUJIFILM Endoscopic CO2 Regulator GW-100

K180711 · Fujifilm Corporation · Gastroenterology & Urology
May 2018
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K180711 is an FDA 510(k) clearance for the FUJIFILM Endoscopic CO2 Regulator GW-100, a Insufflator, Automatic Carbon-dioxide For Endoscope (Class II — Special Controls, product code FCX), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on May 25, 2018, 67 days after receiving the submission on March 19, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number K180711 FDA.gov
FDA Decision Cleared SESE
Date Received March 19, 2018
Decision Date May 25, 2018
Days to Decision 67 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FCX — Insufflator, Automatic Carbon-dioxide For Endoscope
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.1500

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