510(k) Report

Devices descending from K071845

19 later devices reach Relieva Luma Sinus Illumination System, Model Sis-100A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—
+1K120280Relieva Seeker Balloon Sinuplasty SystemAcclarent, Inc.20122—
+1K111763Pathassist Light FiberEntellus Medical, Inc.20118—
+1K110158Illuminating Sinus SeekerEntellus Medical, Inc.20113—
+2K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—
+2K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+2K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+2K140160Relieva Scout Sinus Dilation SystemAcclarent, Inc.20140—
+2K120962Pathassist Light FiberEntellus Medical, Inc.20127—
+2K113522Pathassist Light SeekerEntellus Medical, Inc.20122—
+3K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+3K120735Pathassit Light SeekerEntellus Medical, Inc.20121—
+4K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+4K133563Pathassist Light SeekerEntellus Medical, Inc.20130—
+5K212774VenSure LightGuideIntersect Ent.20221—
+5K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+6K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+6K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+6K201398SINUSPRIME Dilation SystemStryker Ent20200—