510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+17K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+18K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+18K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+18K201398SINUSPRIME Dilation SystemStryker Ent20200—
+18K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+19K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+19K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+20K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—