FDA 510(k) Applications for Medical Device Product Code: FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope)

FDA 510(k) Applications for Medical Device Product Code "FCX"
(Insufflator, Automatic Carbon-Dioxide For Endoscope)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K190985	BAROnova, Inc.	BAROnova Insufflation System, BAROnova Accessory Kit	05/14/2019
K123047	BRACCO DIAGNOSTIC, INC.	BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SET	08/06/2013
K132192	BRACCO DIAGNOSTIC, INC.	BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATOR	02/14/2014
K111648	BRACCO DIAGNOSTIC, INC.	BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR	11/03/2011
K113310	BYRNE MEDICAL, INC.	ENDOGATER AVANTAGE CO2 INSUFFLATOR	06/20/2012
K053008	E-Z-EM, INC.	E-Z-EM ENDOSCOPIC CO2 REGULATOR	12/27/2005
K030854	E-Z-EM, INC.	PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400	04/16/2003
K013219	E-Z-EM, INC.	PROTOCO2L INSUFFLATOR MODEL 6400	02/19/2002
K180711	FUJIFILM Corporation	FUJIFILM Endoscopic CO2 Regulator GW-100	05/25/2018
K133976	FUJIFILM MEDICAL SYSTEM U.S.A., INC.	FUJIFILM ENDOSCOPIC CO2 REGULATOR	09/09/2014
K201096	Karl Storz Endoscopy America, Inc.	CO2mbiLED	06/23/2020
K090879	LEXION MEDICAL, LLC.	INSUFLOW CO2IONSHIELD	07/23/2009
K162332	NEXCORE TECHNOLOGY, LLC	Nexcore GI Insufflator	09/29/2016
K063786	OLYMPUS MEDICAL SYSTEMS CORPORATION	ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2	03/05/2007
K202922	Palliare Ltd.	END 200 Endoscopic Tubeset	07/08/2021
K230474	Palliare Ltd.	EVA5 Insufflator	03/24/2023