510(k) Report

Devices descending from K990354

180 later devices reach Endosheath through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+1K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…Rtc Inc.-Memcath Technologies, LLC20060—
+1K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC20060—
+1K050972Vision-Sciences Ent-3000 ScopeVision-Sciences, Inc.2005302
+1K041077Imalux Oct Probe GuideImalux Corporation200410—
+1K040984Vision Sciences Model Ent-2000V Flexible Nasopharyngo-LaryngoscopeVision-Sciences, Inc.200430—
+1K032688Colonosight Model 510BSightline Technologies, Ltd.200438—
+1K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.200392—
+1K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030—
+1K024095Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc.200331—
+1K012543Vision Sciences Endosheath SystemVision-Sciences, Inc.2002157—
+1K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002157—
+2K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+2K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+2K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+2K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc.20101—
+2K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+2K091305ClearpathEasyglide, Ltd.200913—
+2K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc.200966—
+2K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+2K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI20089—
+2K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc.200815—
+2K072073Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Vision-Sciences, Inc.200729—
+2K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc.200770—
+2K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+2K071903Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc.20073—
+2K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+2K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+2K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc.20052—
+2K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+3K260503Triton 1 SystemNeptune Medical, Inc.20260—
+3K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.20220—
+3K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG20200—
+3K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC20190—
+3K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+3K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+3K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+3K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+3K1629163NT endoscopy system3nt Medical, Ltd.20173—
+3K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+3K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+3K161791Aer-O-Scope Colonoscope SystemGi View, Ltd.20160—
+3K150776Medrobotics Flex SystemMedrobotics Corporation20151—
+3K141286Aer-O-Scope Colonoscope SystemGi View, Ltd.20142—
+3K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+3K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+3K122134Flexlite CameraSpine View, Inc.20120—
+3K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+3K120289Peerscope SystemPeermedical20126—
+3K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+3K112318Clearpath 24Promedic, Inc.20120—
+3K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd.20121—
+3K113050Clearpath Lower GIEasyglide, Ltd.20128—
+3K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112—
+3K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+3K102366Finess EndoscopeEntellus Medical, Inc.20110—
+3K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+3K101094ClearjetEasyglide, Ltd.20100—
+3K093779Clearpath UgiEasyglide, Ltd.201010—
+3K091829PLS Portable Light SourceOptim, Inc.20099—
+3K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC20090—
+3K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+3K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+4K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+4K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+4K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+4K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+4K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+4K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+4K190669EndoticsEra Endoscopy S.R.L.20200—
+4K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+4K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+4K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+4K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S201640—
+4K160766Ambu USR, Ambu MAmbu A/S201614—
+4K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+4K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+4K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+4K133311EndoledOlympus Winter & Ibe GmbH20140—
+4K133941Mitek ArthroscopesMedos International SARL20140—
+4K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd.20130—
+4K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+4K130718Peerscope SystemPeermedical, Ltd.20135—
+4K123359OVS1 Video SystemOlive Medical Corp.20121—
+4K113166Clearpath Upper GIEasyglide, Ltd.20120—
+4K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+5K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+5K203566Tablet ApplicationSmith & Nephew20211—
+5K193095Ambu aScope 4 CystoAmbu A/S202013—
+5K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+5K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+5K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+5K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—
+5K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S201839—
+5K173392Pure-Vu SystemMotus GI Medical Technologies, Ltd.20176—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems20150—