510(k) Report

Devices descending from K111763

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120962Pathassist Light FiberEntellus Medical, Inc.20127—
+2K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+3K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+4K212774VenSure LightGuideIntersect Ent.20221—
+4K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+5K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+5K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+5K201398SINUSPRIME Dilation SystemStryker Ent20200—