510(k) Report

Devices descending from K040836

37 later devices reach Disposable Overtube through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182520Flexible OvertubeSumitomo Bakelite Co., Ltd.20190—
+1K122270Overtube Endoscopic Access SystemApollo Endosurgery, Inc.20120—
+1K100081Enteroscopy Overtube, Model 00712140United States Endoscopy Group, Inc.20103—
+1K092221Colonic Splinting Overtube, Model 00711145United States Endoscopy Group, Inc.20095—
+1K082589Barosense Endogastric Tube (Egt), Model F0034Barosense, Inc.20091—
+1K080550Megachannel Endoscopic Overtube, Model OT22Minos Medical20084—
+1K073484Ethicon Endo Surgery Sheath and Articulating Accessory Channel - Gastroscope, Model…Ethicon Endo-Surgery, Inc.20080—
+1K063654EndoguideKms Medical, LLC20077—
+1K060235Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.20065—
+1K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.200518—
+2K192691PatCom Single-Use IntroducerH&A Mui Enterprises, Inc.20200—
+2K191415Pathfinder Endoscope OvertubeNeptune Medical, Inc.20196—
+2K153698LumenR Tissue Retractor SystemLumenr, LLC20163—
+2K123013Endoscopic IntroducerNovadaq Technologies, Inc.20130—
+2K120126Barosense Endogastric Tube and Introducer BougieBarosense, Inc.20120—
+2K110531Endoflip EcdCrospon, Ltd.20111—
+2K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc.20097—
+2K080050Spirus Medical Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.20084—
+2K062805Modification to Endo-EaseSpirus Medical, Inc.20061—
+3K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.20260—
+3K230752Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)FUJIFILM Healthcare Americas Corporation20231—
+3K211301Pathfinder Endoscope OvertubeNeptune Medical, Inc.20213—
+3K173400ORISE Tissue Retractor SystemBoston Scientific20182—
+3K150083Sidecar External Working ChannelC2 Therapeutics20150—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K080317Enolok-for Endoscoped with 12.8>Dia.<13.3MM Shaft Diameter, Model Ael; Endoscopes with…Syntheon, LLC20080—
+4K243091Over-tube (TR-1108A)Fujifilm Corporation20240—
+4K240853Pathfinder® CR SystemNeptune Medical, Inc.20240—
+4K230801Pathfinder Endoscope Overtube with Balloon DeviceNeptune Medical, Inc.20230—
+4K182540DiLumen Endolumenal Interventional PlatformLumendi, LLC20181—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+4K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+5K210851DiLumen Endolumenal Interventional Platform (DiLumen)Lumendi, LLC20210—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—