510(k) Report

Devices descending from K822846

76 later devices reach Pentax FC-38LA & FC-38SA Colonofiber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.1996723
+1K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.1996421
+2K093037Pentex EC-3890LIPentax Medical Company20090—
+2K042741EC-3870CILK, Confocal Video ColonoscopePentax Medical Company2004152
+2K032688Colonosight Model 510BSightline Technologies, Ltd.200438—
+2K964131EndoscopeAkos Biomedical, Inc.19970—
+2K962897EG-3400, Video GastroscopePentax Precision Instrument Corp.199601
+2K962460EG-3800T, Video GastroscopePentax Precision Instrument Corp.199601
+2K961568ED-344OTPentax Precision Instrument Corp.19960—
+2K961564EG-2940, Video GastroscopePentax Precision Instrument Corp.1996102
+2K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp.1996391
+2K961567ES-3840, Video SigmoidoscopePentax Precision Instrument Corp.19960—
+2K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp.199639—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc.20101—
+3K091305ClearpathEasyglide, Ltd.200913—
+3K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI20089—
+3K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+3K061666Cellvizio with Confocal Miniprobes, Model F-600; Coloflex and GastroflexMauna Kea Technologies200613—
+3K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+3K051585F-400 SystemMauna Kea Technologies200513—
+3K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp.20029—
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC20190—
+4K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K133466Cellvizio 100 Series System with Confocal Miniprobes (TM)Mauna Kea Technologies20147—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K120289Peerscope SystemPeermedical20126—
+4K112318Clearpath 24Promedic, Inc.20120—
+4K113050Clearpath Lower GIEasyglide, Ltd.20128—
+4K111047Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies, Inc.201112—
+4K101094ClearjetEasyglide, Ltd.20100—
+4K093779Clearpath UgiEasyglide, Ltd.201010—
+4K063847Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700Fujinon, Inc.200781
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20176—
+5K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+5K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+5K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+5K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20157—
+5K141358Cellvizio 100 Series with System Confocal MiniprobesMauna Kea Technologies20149—
+5K132389Cellvizio 100 Series System and Cellvizio System with Confocal Miniprobes; Uroflex B and…Daniel & Daniel Consulting201410—
+5K130718Peerscope SystemPeermedical, Ltd.20135—
+5K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc.201241
+5K113166Clearpath Upper GIEasyglide, Ltd.20120—
+5K111243Fujinon Ultrasonic ProcessorFujinon, Inc.20117—
+6K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies20200—
+6K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies20202—
+6K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesMauna Kea Technologies20194—
+6K181763FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20183—
+6K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+6K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies20167—
+6K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc.20161—
+6K132839Fuse 1C Colonoscopy SystemEndochoice, Inc.20142—
+6K131422Peerscope SystemEndochoice, Inc.20132—
+7K243711Confocal Microprobe Imaging System (BrightP980); Confocal Microprobe Imaging System…Wuxi Hisky Medical Technologies Co., Ltd.20250—
+7K241275Histolog® Scanner (Hardware 2.4, Software 3.3)Samantree Medical SA20240—
+7K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies20210—
+7K200850Fujifilm Ultrasonic ProcessorFujifilm Corporation20200—
+7K183433FUJIFILM Ultrasonic EndoscopeFujifilm Corporation20192—
+7K181437Pure Vu SystemMotus GI Medical Technologies, Ltd.20185—
+7K152182Fuse Gastroscopy SystemEndochoice, Inc.20151—
+7K141598Fuse Colonoscopy SystemEndochoice, Inc.201411
+8K221238FUJIFILM Ultrasonic Endoscope EG-740UTFujifilm Corporation20220—
+8K221952Endoscope Model EG-580UT and Endoscope Model EG-580URFujifilm Corporation20220—
+8K191220Pure Vu SystemMotus GI Medical Technologies, Ltd.20194—
+8K160275Fuse Endoscopic System with FuseBox ProcessorEndochoice, Inc.20160—
+9K220007Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20222—
+9K210981Pure Vu SystemMotus GI Medical Technologies, Ltd.20210—
+10K232922Pure-Vu EVS SystemMotus GI Medical Technologies, Ltd.20231—
+11K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—