510(k) Report

Devices descending from K030854

10 later devices reach PROTOCO2L Colon Insufflator with Performance Improvements, Model 6400 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132192Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorBracco Diagnostic, Inc.20141—
+1K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+1K090879Insuflow CO2IONSHIELDLexion Medical, LLC20090—
+2K240847MedicCO2LON (MedicCO2LON)Ide Vision, Ltd.20240—
+2K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+2K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+2K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+2K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K190669EndoticsEra Endoscopy S.R.L.20200—
+3K173085invendoscopy E210 SystemInvendo Medical GmbH20180—