510(k) Report

Devices descending from K014290

119 later devices reach Entec Plasma Wands through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+8K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+8K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+8K121943Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201217—
+8K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+9K160770Vent-Os Sinus Dilation familySinusys Corporation20160—
+9K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+9K132440Xpress Multi-Sinus Dilation ToolEntellus Medical, Inc.201314—
+10K142252XprESS Multi-Sinus Dilation ToolEntellus Medical, Inc.201413—
+11K152434XprESS Multi-Sinus Dilation SystemEntellus Medical, Inc.201511—
+12K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+12K163509XprESS ENT Dilation SystemEntellus Medical, Inc.20179—
+13K220027Audion ET dilation systemEntellus Medical, Inc.20220—
+13K210841NuVent Eustachian Tube Dilation BalloonMedtronic Xomed, Inc.20210—
+13K201398SINUSPRIME Dilation SystemStryker Ent20200—
+13K171761ACCLARENT AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20185—
+14K230742ACCLARENT AERA Eustachian Tube Dilation SystemAcclarent, Inc.20231—
+14K223542TubaVent Balloon Dilatation SystemSpiggle & Theis Medizintechnik GmbH20230—
+15K253612Acclarent AERA Eustachian Tube Balloon Dilation SystemAcclarent, Inc.20260—