510(k) Report

Devices descending from K133573

28 later devices reach Fiagon Navigation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4DFiagon GmbH20211—
+1K193502TGS Universal Headrest with Mounting ArmStryker Ent20200—
+1K161491Scopis Hybrid Navigation System EMScopis GmbH20173—
+1K162176Fiagon Navigation SystemFiagon GmbH20164—
+1K161701CARTO ENT SystemBiosense Webster20163—
+1K161555KARL STORZ NAV1 Electromagnetic Navigation SystemKarl Storz Endoscopy America, Inc.20162—
+1K150473FlexPointer 1.5 mmFiagon GmbH20152—
+1K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+2K261540Cube 4D Navigation System, VirtuEye ProFiagon GmbH20260—
+2K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+2K201174TruDi CuretteAcclarent, Inc.20200—
+2K193453TruDi ProbeAcclarent, Inc.20200—
+2K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+2K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+2K192397TruDi Navigation SystemBiosense Webster202011
+2K180948TruDi NAV Suction InstrumentsAcclarent, Inc.201805
+2K173628Acclarent ENT Navigation SystemAcclarent, Inc.20182—
+2K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+2K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+2K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+2K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+2K160369GuideWireFiagon GmbH20163—
+3K231862TruDi® Navigation System V3 (FG-2000-00)Acclarent, Inc.202301
+3K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+3K190532TruDi NAV WireAcclarent, Inc.20190—
+3K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+3K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+4K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—