510(k) Report

Devices descending from K130503

6 later devices reach Pathassist Led Light Fiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+2K212774VenSure LightGuideIntersect Ent.20221—
+2K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+3K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+3K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+3K201398SINUSPRIME Dilation SystemStryker Ent20200—