510(k) Report

Devices descending from K012232

15 later devices reach Insight, Model S980000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142327smARTrack Feeding Tube SystemArt Healthcare, Ltd.20152—
+1K092850EndoflipCrospon, Ltd.20099—
+1K091070Manoscan Motility with Impedance Visualization SystemSierra Scientific Instruments, Inc.20091—
+2K230206Entarik Feeding Tube System; Entarik Feeding TubeGravitas Medical, Inc.20231—
+2K160725EndoFLIPCrospon, Ltd.20164—
+2K151086ManoScan SystemGiven Imaging, Ltd.20160—
+2K130906Endoflip CatheterCrospon, Ltd.20130—
+2K120997Barostat Software OptionCrospon, Ltd.20127—
+2K102214Endo FlipCrospon, Ltd.20101—
+3K241169Entarik NI Feeding Tube SystemGravitas Medical, Inc.20240—
+3K183072EndoFLIP SystemCrospon, Ltd.201921
+3K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd.20170—
+3K132337Esoflip Balloon Dilation CatheterCrospon, Ltd.201301
+4K223705EndoflipTM 300Covidien, LLC20231—
+5K231861EndoflipTM 300 SystemCovidien, LLC20230—