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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 the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Corporation. It received FDA 510(k) clearance on 2018-05-25 under 510(k) 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. The listed applicant is Fujifilm Corporation. The 510(k) number is K180711.

When did FUJIFILM Endoscopic CO2 Regulator GW-100 receive FDA 510(k) clearance?

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

Who is the listed applicant for FUJIFILM Endoscopic CO2 Regulator GW-100?

The FDA 510(k) record lists Fujifilm Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Fujifilm Corporation as applicant

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Related Devices (Code: FCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262152VS-370CF, VS-370CTVISION MEDICAL Co., Ltd.K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.K230474EVA5 InsufflatorPalliare , Ltd.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.

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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