510(k) Report

Devices descending from K091829

9 later devices reach PLS Portable Light Source through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133311EndoledOlympus Winter & Ibe GmbH20140—
+1K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+1K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+2K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+3K212774VenSure LightGuideIntersect Ent.20221—
+3K152435PassAssist LED Light FiberEntellus Medical, Inc.20152—
+4K230065VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav…Fiagon GmbH20230—
+4K230258BB 8 Sinus Dilation KitExcelent, Inc.20230—
+4K201398SINUSPRIME Dilation SystemStryker Ent20200—