EVA5 Insufflator

FDA 510(k) K230474 · Palliare , Ltd.

Substantially Equivalent

510(k) numberK230474

Submission

Device name
EVA5 Insufflator
Applicant
Palliare , Ltd.
Galway, IE
Received
February 22, 2023
Decision date
March 24, 2023
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1500
Specialty
Gastroenterology, Urology

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510(k)DeviceApplicantDecision
K262152VS-370CF, VS-370CTFCX · Traditional VISION MEDICAL Co., Ltd.07/24/2026SE
K240847MedicCO2LON (MedicCO2LON)FCX · Traditional Ide Vision, Ltd.10/30/2024SE
K202922END 200 Endoscopic TubesetFCX · Traditional Palliare , Ltd.07/08/2021SE
K201096CO2mbiLEDFCX · Traditional Karl Storz Endoscopy America, Inc.06/23/2020SE
K190985BAROnova Insufflation System, BAROnova Accessory KitFCX · Traditional Baronova, Inc.05/14/2019SESK
K180711FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special Fujifilm Corporation05/25/2018SE
K162332Nexcore GI InsufflatorFCX · Traditional Nexcore Technology, LLC09/29/2016SE
K133976Fujifilm Endoscopic CO2 RegulatorFCX · Traditional Fujifilm Medical System U.S.A., Inc.09/09/2014SE
K132192Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional Bracco Diagnostic, Inc.02/14/2014SE
K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetFCX · Traditional Bracco Diagnostic, Inc.08/06/2013SE

More from Bracco Diagnostic, Inc.

510(k)DeviceDecision
K232902EVA15 insufflatorHIF · Traditional 05/02/2024SE
K222901EVA15 insufflatorHIF · Traditional 01/27/2023SE
K202922END 200 Endoscopic TubesetFCX · Traditional 07/08/2021SE
K202799EVA15HIF · Special 10/21/2020SE
K193520EVA 15 InsufflatorHIF · Traditional 07/23/2020SE

Questions and answers

When was EVA5 Insufflator cleared by the FDA?

EVA5 Insufflator (K230474) received a 510(k) decision of Substantially Equivalent on March 24, 2023, 30 days after the submission was received.

What is the product code of K230474?

The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.