510(k) Report

Devices descending from K961591

184 later devices reach Disposable Endosheath for E-F100 Flexible Nasopharyngoscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K990354EndosheathVision-Sciences, Inc.1999180—
+1K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc.1996158—
+1K964100Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…Vision-Sciences, Inc.19960—
+1K963344Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeVision-Sciences, Inc.19962—
+2K101734Visionscope High Definition Endoscopy Camera System with; Camera Control Unit; Camera…Visionscope Technologies, LLC20107—
+2K061663Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for…Rtc Inc.-Memcath Technologies, LLC20060—
+2K061324Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC20060—
+2K050972Vision-Sciences Ent-3000 ScopeVision-Sciences, Inc.2005302
+2K041077Imalux Oct Probe GuideImalux Corporation200410—
+2K040984Vision Sciences Model Ent-2000V Flexible Nasopharyngo-LaryngoscopeVision-Sciences, Inc.200430—
+2K032688Colonosight Model 510BSightline Technologies, Ltd.200438—
+2K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.200392—
+2K031790Slide-on Endosheath System for Sensory TestingVision-Sciences, Inc.20030—
+2K024095Modification to Vision Sciences Endosheath SystemVision-Sciences, Inc.200331—
+2K012543Vision Sciences Endosheath SystemVision-Sciences, Inc.2002157—
+2K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002157—
+3K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera…Smith & Nephew20166—
+3K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126—
+3K112770Nvision Vle Imaging System, Nvision Vle CatheterNinepoint Medical, Inc.20119—
+3K100966Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc.20101—
+3K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc.201002
+3K091305ClearpathEasyglide, Ltd.200913—
+3K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc.200966—
+3K082569Entellus Medical Flexible Endoscope and EyepieceEntellus Medical, Inc.20085—
+3K081004Protectiscope CS Colonoscope, Non-IntrapullStryker GI20089—
+3K080622Entity Nasoview Led Nasopharyngoscope, Model 006105Optim, Inc.200815—
+3K072073Vision-Sciences Ent-5000 and Ent-5100 Video Ent Scope with Endosheath System…Vision-Sciences, Inc.200729—
+3K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc.200770—
+3K070622Neoguide Endoscopy SystemNeoguide Systems, Inc.200712—
+3K071903Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc.20073—
+3K053560Modified Endosheath System for Vsi Flexible CystoscopeVision-Sciences, Inc.200623—
+3K052930Navigator Endoscopy SystemNeoguide Systems, Inc.200613—
+3K051972Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc.20052—
+3K040215Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath SystemVision-Sciences, Inc.200426—
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.20220—
+4K192523CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG20200—
+4K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC20190—
+4K191177LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K…Smith and Nephew, Inc.20191—
+4K190367Smith & Nephew Tablet ApplicationSmith & Nephew20193—
+4K181292PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video ProcessorCogentix Medical, Inc.20180—
+4K162330Flex Robotic System and Flex Colorectal DriveMedrobotics Corporation201712
+4K1629163NT endoscopy system3nt Medical, Ltd.20173—
+4K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd.20160—
+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—
+4K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S201364—
+4K120800Nvision Vle Imaging SystemNinepoint Medical, Inc.20136—
+4K122134Flexlite CameraSpine View, Inc.20120—
+4K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh20125—
+4K120289Peerscope SystemPeermedical20126—
+4K121195Nvision Vle Imaging System Nvision Vle CatheterNinepoint Medical, Inc.20120—
+4K112318Clearpath 24Promedic, Inc.20120—
+4K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd.20121—
+4K113050Clearpath Lower GIEasyglide, Ltd.20128—
+4K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112—
+4K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences…Vision-Sciences, Inc.20117—
+4K102366Finess EndoscopeEntellus Medical, Inc.20110—
+4K100577Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20114—
+4K101094ClearjetEasyglide, Ltd.20100—
+4K093779Clearpath UgiEasyglide, Ltd.201010—
+4K091829PLS Portable Light SourceOptim, Inc.20099—
+4K082038Clarus Video Airway Endoscope, Models 30000-V and 30003-VClarus Medical, LLC20090—
+4K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc.200720—
+4K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc.20075—
+5K253905PrimeSight UltraView SystemCogentix Medical, Inc.20260—
+5K221740Smith & Nephew Intellio 4K Camera Control Unit, Network Enabled (72205447), Smith &…Smith and Nephew, Inc.20220—
+5K220004Zsquare ENT-Flex EndoscopeZsquare, Ltd.20220—
+5K202727Peregrine Endoscopy System3nt Medical, Ltd.20210—
+5K192305Colibri Endoscopy System3nt Medical, Ltd.20200—
+5K192876INTELLIO Tablet ApplicationSmith & Nephew20202—
+5K190669EndoticsEra Endoscopy S.R.L.20200—
+5K183256GlideScope BFlex Single-Use Bronchoscope SystemVerathon Medical (Canada) Ulc20196—
+5K181909Luminelle DTx Hysteroscopy SystemUvision360, Inc.20183—
+5K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+5K170453Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+5K172036Medrobotics Flex Robotic SystemMedrobotics Corporation20170—
+5K160015Pure VuMotus GI Medical Technologies, Ltd.20167—
+5K161656Ambu 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—
+5K160766Ambu USR, Ambu MAmbu A/S201614—
+5K152466Neo-Bronchoscope -Digital Video Bronchoscopy System (Rigid/Flexible)Prosurg, Inc.20160—
+5K150248ORL Video NasoPharyngo-LarngoscopeJedmed Instrument Company20150—
+5K143678NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation AccessoryNinepoint Medical, Inc.201551
+5K133311EndoledOlympus Winter & Ibe GmbH20140—
+5K133941Mitek ArthroscopesMedos International SARL20140—
+5K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd.20130—
+5K130503Pathassist Led Light FiberEntellus Medical, Inc.20136—
+5K130718Peerscope SystemPeermedical, Ltd.20135—
+5K123359OVS1 Video SystemOlive Medical Corp.20121—
+5K113166Clearpath Upper GIEasyglide, Ltd.20120—
+5K110097Acclarent Cyclops Multi-Angle EndoscopeAcclarent, Inc.20113—
+6K211947GlideScope BFlex 2.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20213—
+6K203566Tablet ApplicationSmith & Nephew20211—
+6K193095Ambu aScope 4 CystoAmbu A/S202013—
+6K193488GlideScope BFlex 3.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20204—
+6K191948GlideScope BFlex 5.8 Single-Use BronchoscopeVerathon Medical (Canada) Ulc20195—
+6K190827Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath RigidUvision360, Inc.20192—
+6K182261NvisionVLE Imaging System, NvisionVLE Optical ProbeNinepoint Medical, Inc.20181—