510(k) Report

Devices descending from K864821

16 later devices reach Airway Fiberscopes, Models LS-9, 0L-1, 0L-2 & PL-2 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc.200815—
+2K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+2K091829PLS Portable Light SourceOptim, Inc.20099—
+3K133311EndoledOlympus Winter & Ibe GmbH20140—
+3K133941Mitek ArthroscopesMedos International SARL20140—
+3K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+3K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+3K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+4K141916Pathassist Led Light FiberEntellus Medical, Inc.20145—
+4K132433Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20141—
+5K212774VenSure LightGuideIntersect Ent.20221—
+5K153701ULYSS Multi View SinuscopeSopro-Comeg GmbH20160—
+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—