510(k) Report

Devices descending from K130608

17 later devices reach Quadcut through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K262235ApexCut ™ Blade with Automated EM Tracking (187BL4012EM);ApexCut ™ Blade with Automated…Medtronic Xomed, Inc.20260—
+1K221037TruDi Shaver BladeAcclarent, Inc.20220—
+1K133665Malleable Suction InstrumentsMedtronic Navigation, Inc.201414—
+2K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+3K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+3K171661Scopis Extended Instrument Set EMScopis GmbH20173—
+3K163416Fiagon Navigation – PointerTube Straight and PointerTube KeatFiagon GmbH20170—
+3K161697Acclarent NavWire Sinus Navigation GuidewireAcclarent, Inc.20163—
+3K160479PointerShell Universal, PointerShell LSFiagon GmbH20160—
+3K160369GuideWireFiagon GmbH20163—
+4K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+4K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+4K190532TruDi NAV WireAcclarent, Inc.20190—
+4K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+4K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+5K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+5K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—