510(k) Report

Devices descending from K141456

13 later devices reach The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+1K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+1K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+1K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+1K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+1K160369GuideWireFiagon GmbH20163—
+2K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+2K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+2K190532TruDi NAV WireAcclarent, Inc.20190—
+2K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+2K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+3K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+3K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—