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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 the device name listed in this FDA 510(k) record. The listed applicant is Palliare , Ltd.. It received FDA 510(k) clearance on 2023-03-24 under 510(k) 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. The listed applicant is Palliare , Ltd.. The 510(k) number is K230474.

When did EVA5 Insufflator receive FDA 510(k) clearance?

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

Who is the listed applicant for EVA5 Insufflator?

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

What is the FDA product code for EVA5 Insufflator?

The FDA product code for EVA5 Insufflator is FCX.

Other records listing Palliare , Ltd. as applicant

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.

K232902EVA15 insufflatorK222901EVA15 insufflatorK202922END 200 Endoscopic TubesetK202799EVA15K193520EVA 15 Insufflator

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.K202922END 200 Endoscopic TubesetPalliare , Ltd.K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation

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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