510(k) Report

Devices descending from K053008

11 later devices reach E-Z-EM Endoscopic CO2 Regulator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202922END 200 Endoscopic TubesetPalliare, Ltd.20210—
+1K123047Bracco Diagnostics Inc. CO2 Endoscopic Insufflator in Line Tubing SetBracco Diagnostic, Inc.20130—
+1K113310Endogater Avantage CO2 InsufflatorByrne Medical, Inc.20120—
+1K111648Bracco Diagnostics, Inc. CO2MPACT Endodcopic InsufflatorBracco Diagnostic, Inc.201131
+1K090879Insuflow CO2IONSHIELDLexion Medical, LLC20090—
+1K063786Endoscopic Insufflation Unit, Model Xecr-2Olympus Medical Systems Corporation20072—
+2K201096CO2mbiLEDKarl Storz Endoscopy America, Inc.20200—
+2K190985BAROnova Insufflation System, BAROnova Accessory KitBaronova, Inc.20190—
+2K162332Nexcore GI InsufflatorNexcore Technology, LLC20160—
+2K133976Fujifilm Endoscopic CO2 RegulatorFujifilm Medical System U.S.A., Inc.20141—
+3K180711FUJIFILM Endoscopic CO2 Regulator GW-100Fujifilm Corporation20180—