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FDA 510(k)

FUJIFILM Endoscopic CO2 Regulator GW-100

K-Number: K180711 · 2018-05-25

ApplicantFujifilm Corporation
Decision Date2018-05-25
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Endoscopic CO2 Regulator GW-100 is a medical device manufactured by Fujifilm Corporation. It received FDA 510(k) clearance on 2018-05-25 under approval number K180711. The device is classified under product code FCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Endoscopic CO2 Regulator GW-100?

FUJIFILM Endoscopic CO2 Regulator GW-100 is a medical device that received FDA 510(k) clearance on 2018-05-25. It is manufactured by Fujifilm Corporation. The 510(k) number is K180711.

When was FUJIFILM Endoscopic CO2 Regulator GW-100 approved by the FDA?

FUJIFILM Endoscopic CO2 Regulator GW-100 received FDA 510(k) clearance on 2018-05-25, under approval number K180711.

What company makes FUJIFILM Endoscopic CO2 Regulator GW-100?

FUJIFILM Endoscopic CO2 Regulator GW-100 is manufactured by Fujifilm Corporation.

What is the FDA product code for FUJIFILM Endoscopic CO2 Regulator GW-100?

The FDA product code for FUJIFILM Endoscopic CO2 Regulator GW-100 is FCX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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