510(k) Report

Devices descending from K171761

5 later devices reach ACCLARENT AERA Eustachian Tube Balloon Dilation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+1K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+1K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+1K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+2K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—