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 |
|
|