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FDA 510(k)

EVA5 Insufflator

K-Number: K230474 · 2023-03-24

ApplicantPalliare , Ltd.
Decision Date2023-03-24
Product CodeFCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVA5 Insufflator is a medical device manufactured by Palliare , Ltd.. It received FDA 510(k) clearance on 2023-03-24 under approval number K230474. 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 EVA5 Insufflator?

EVA5 Insufflator is a medical device that received FDA 510(k) clearance on 2023-03-24. It is manufactured by Palliare , Ltd.. The 510(k) number is K230474.

When was EVA5 Insufflator approved by the FDA?

EVA5 Insufflator received FDA 510(k) clearance on 2023-03-24, under approval number K230474.

What company makes EVA5 Insufflator?

EVA5 Insufflator is manufactured by Palliare , Ltd..

What is the FDA product code for EVA5 Insufflator?

The FDA product code for EVA5 Insufflator is FCX.

Other Devices by Palliare , Ltd.

K202799EVA15 K193520EVA 15 Insufflator K202922END 200 Endoscopic Tubeset K222901EVA15 insufflator K232902EVA15 insufflator

Related Devices (Code: FCX)

K162332Nexcore GI InsufflatorNexcore Technology, LLC K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc. K201096CO2mbiLEDKarl Storz Endoscopy America, Inc. K202922END 200 Endoscopic TubesetPalliare , Ltd. K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.

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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