510(k) Report

Devices descending from K133665

14 later devices reach Malleable Suction Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141456The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…Fiagon GmbH201413—
+2K200041FlexPointer 1.5 Single Use, FlexTube 3 Single UseFiagon GmbH20200—
+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—
+3K202609Instrument Clamps ElectromagneticStryker Corporation20200—
+3K193118TGS Guidewire and updated Scopis SoftwareStryker Ent20201—
+3K190532TruDi NAV WireAcclarent, Inc.20190—
+3K171687Relieva SpinPlus Nav Balloon Sinuplasty SystemAcclarent, Inc.20171—
+3K161940Guidewire 0.6 Single UseFiagon GmbH20162—
+4K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software…Stryker Corporation202201
+4K201115Next Generation Balloon Dilation SystemAcclarent, Inc.20200—