FDA.reportPublic FDA data

510(k) K240847

Device
MedicCO2LON (MedicCO2LON)
Applicant
Ide Vision, Ltd.
510(k) number
K240847
Product code
FCX
Decision
Substantially Equivalent (SESE)
Decision date
2024-10-30
Date received
2024-03-27
Regulation
876.1500
Classification name
Insufflator, Automatic Carbon-Dioxide For Endoscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nicholas See
Address
Lodge Way Portskewett Caldicot GB NP265PS NP265PS

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code FCX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230474EVA5 InsufflatorPalliare , Ltd.2023-03-24
K202922END 200 Endoscopic TubesetPalliare , Ltd.2021-07-08
K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.2020-06-23
K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.2019-05-14
K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation2018-05-25
K162332Nexcore GI InsufflatorNexcore Technology, LLC2016-09-29
K133976FUJIFILM ENDOSCOPIC CO2 REGULATORFujifilm Medical System U.S.A., Inc.2014-09-09
K132192BRACCO DIAGNOSTICS INC. PROTOCO, L TOUCH COLON INSUFFLATORBracco Diagnostic, Inc.2014-02-14
K123047BRACCO DIAGNOSTICS INC. CO2 ENDOSCOPIC INSUFFLATOR IN LINE TUBING SETBracco Diagnostic, Inc.2013-08-06
K113310ENDOGATER AVANTAGE CO2 INSUFFLATORByrne Medical, Inc.2012-06-20
K111648BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATORBracco Diagnostic, Inc.2011-11-03
K090879INSUFLOW CO2IONSHIELDLexion Medical, LLC2009-07-23
K063786ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2Olympus Medical Systems Corporation2007-03-05
K053008E-Z-EM ENDOSCOPIC CO2 REGULATORE-Z-Em, Inc.2005-12-27
K030854PROTOCO2L COLON INSUFFLATOR WITH PERFORMANCE IMPROVEMENTS, MODEL 6400E-Z-Em, Inc.2003-04-16