510(k) Report

Devices descending from K113351

5 later devices reach Cortrak Enteral Access Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191340CORTRAK* 2 Equilateral Enteral Access SystemAvanos Medical, Inc.20191Class I
+1K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd.20152—
+2K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc.20231—
+2K220588Avanos* CORTRAK* 2 Enteral Access System (EAS)Avanos Medical, Inc.20220—
+3K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc.20240—