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FCX — Insufflator, Automatic Carbon-Dioxide For Endoscope Class II

FDA Device Classification

Classification Details

Product Code
FCX
Device Class
Class II
Regulation Number
876.1500
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240847ide visionMedicCO2LON (MedicCO2LON)October 30, 2024
K230474palliareEVA5 InsufflatorMarch 24, 2023
K202922palliareEND 200 Endoscopic TubesetJuly 8, 2021
K201096karl storz endoscopy americaCO2mbiLEDJune 23, 2020
K190985baronovaBAROnova Insufflation System, BAROnova Accessory KitMay 14, 2019
K180711fujifilm corporationFUJIFILM Endoscopic CO2 Regulator GW-100May 25, 2018
K162332nexcore technologyNexcore GI InsufflatorSeptember 29, 2016
K133976fujifilm medical system u.s.aFUJIFILM ENDOSCOPIC CO2 REGULATORSeptember 9, 2014
K132192bracco diagnosticBRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATORFebruary 14, 2014
K123047bracco diagnosticBRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETAugust 6, 2013
K113310byrne medicalENDOGATER AVANTAGE CO2 INSUFFLATORJune 20, 2012
K111648bracco diagnosticBRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORNovember 3, 2011
K090879lexion medicalINSUFLOW CO2IONSHIELDJuly 23, 2009
K063786olympus medical systems corporationENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2March 5, 2007
K053008e-z-emE-Z-EM ENDOSCOPIC CO2 REGULATORDecember 27, 2005
K030854e-z-emPROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400April 16, 2003
K013219e-z-emPROTOCO2L INSUFFLATOR MODEL 6400February 19, 2002
K945970xylogINSUFFLATOR FILTER TUBING SETDecember 15, 1994
K930581e-z-emE-Z-FLATEJuly 1, 1994
K935059phx technologiesINSUFFLATION TUBING SET, PHX500-082December 22, 1993