510(k) Report

Devices descending from K850020

12 later devices reach Pentax Pne- Ultra-Slim Upper G.I. Fiberscope FG-23 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962897EG-3400, Video GastroscopePentax Precision Instrument Corp.199601
+1K961564EG-2940, Video GastroscopePentax Precision Instrument Corp.1996102
+2K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp.20029—
+3K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+4K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+4K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+5K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+5K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+6K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+6K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—
+7K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+7K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—