510(k) Report

Devices descending from K911580

3 later devices reach Donaldson/Shepards DR/Collar/Shah Vent-Mini Tubes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082188Tympanostomy TubeAcclarent, Inc.20082—
+2K103595Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery SystemAcclarent, Inc.20111—
+3K171239TULA Tube Delivery SystemTusker Medical20170—