510(k) Report

Devices descending from K080679

3 later devices reach Modification to Cortrak Enteral Access Device, Model 20-0900 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182915ENvizion Medical ENvue; ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd.20192—
+2K191387ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd.20191—
+3K203133ENvizion Medical ENvue ENvizion Medical Enteral Feeding TubeEnvizion Medical, Ltd.20210—