510(k) Report

Devices descending from K912120

273 later devices reach Urf-P2 Ureterorenofiberscope/Choledochofiberscope through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200483SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerBoston Scientific Corporation20203—
+1K172298Olympus Urf-P6/P6ROlympus Medical Systems Corp.201825
+1K161147EndoCure Model EUR078AEndocure Technologies, Inc.20160—
+1K021074Visera Cystovideoscope Olympus Cyf Type V/VAOlympus America, Inc.2002268—
+2K221784Single-use Video Pancreaticobiliary Scope, PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20232—
+2K181451Uretero-Reno Videoscope Olympus Urf-V3/V3R, Uretero-Reno Fiberscope Olympus Urf-P7/P7ROlympus Medical Systems Corp.201911
+2K171500Uro-V CystoscopeUroviu Corporation20185—
+2K160766Ambu USR, Ambu MAmbu A/S201614—
+2K062049Evis Exera II 180 SystemOlympus Medical Systems Corporation2006158—
+2K051176Flexible Video Cystoscope/Choledochoscope, Models 7308.061 and 7308.066Richard Wolf Medical Instruments Corp.20050—
+2K030960Ecn Electronic Video CystonephroscopeAcmi Corporation2003103—
+3K252492Visualized Access and Delivery Catheter; PB Digital ControllerMicro-Tech (Nanjing) Co., Ltd.20260—
+3K254153Single-use Video Scope; PB Digital ControllerMirco-Tech (Nanjing) Co., Ltd.20260—
+3K202921Uro-G CystoscopeUroviu Corporation20213—
+3K193095Ambu aScope 4 CystoAmbu A/S202013—
+3K191078BAROnova Access Sheath KitBaronova, Inc.20190—
+3K182876Uro-N CystoscopeUroviu Corporation20190—
+3K133538Visera Cysto-Nephro Videoscope Olympus Cyf Type V2, Visera Cysto-Nephro Videoscope…Olympus Corporation of the Americas201425—
+3K121959Evis Exera Iii Video SystemOlympus Medical Systems Corp.201314Class I
+3K111425Olympus LTF-S190-10, Olumpus Otv-S190, Olympus CLV-S190Olympus Medical Systems Corp.2012341
+3K112680Evis Exera Iii Video SystemOlympus Medical Systems Corporation2012576
+3K100584Evis Exeraii 180 SystemOlympus Medical Systems Corporation20101329
+3K042069Invisio Irl Digital Rigid Laparoscope SystemAcmi Corporation20040—
+3K042225Acmi Invisio Icn, Models Icn-0564 and Icn-0565Acmi Corporation2004101—
+4K260503Triton 1 SystemNeptune Medical, Inc.20260—
+4K252341Evis Exera Iii Bronchovideoscope (Olympus BF-Q190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20260—
+4K251140Zenflow Spring ScopeZenflow, Inc.20250—
+4K242535Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01…Hunan Vathin Medical Instrument Co., Ltd.20240—
+4K240849Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20240—
+4K240227LiNA CystoVu™ HD (CYV-100-5; CYV-101-5); LiNA ScopeVu™ (SCP-100-1)Lina Medical Aps20240—
+4K241500Endoscopic Video Image Processor (RP-IPD-V2000EF); Single-Use Video Flexible…Guangzhou Red Pine Medical Instrument Co., Ltd.20242—
+4K232997EVIS Exera III Gastrointestinal Videoscope GIF-1TH190Olympus Medical Systems Corporation202412
+4K232837Uro-G HD Flexible CystoscopeUroviu Corporation20242—
+4K232043Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C…Guangzhou Red Pine Medical Instrument Co., Ltd.20240—
+4K231118Cystoscope SystemShenzhen HugeMed Medical Technical Development Co., Ltd.20230—
+4K223926VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video BoxMedimaging Integrated Solution, Inc (Miis)20230—
+4K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMStryker20235—
+4K230332Ambu® aScope™ Colon; Ambu® aBox™ 2Ambu A/S20236—
+4K230588Aer-O-Scope Colonoscope SystemGi View, Ltd.20231—
+4K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100…Olympus Medical Systems Corporation20231—
+4K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R)…Olympus Medical Systems Corporation202315
+4K221690Oes Cystonephro Fiberscope (Olympus Cyf-5), Oes Cystonephro Fiberscope (Olympus Cyf-5R)…Olympus Medical Systems Corp.202203
+4K221580Single-Use Flexible CystoscopeHunan Vathin Medical Instrument Co., Ltd.20220—
+4K222162Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20221—
+4K222602Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope…Zhuhai Pusen Medical Technology Co., Ltd.20221—
+4K212202WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope…OTU Medical, Inc.20221—
+4K210052Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without…Saneso, Inc.20221—
+4K212382Ambu® aScope™ Gastro, Ambu® aBox™2Ambu A/S20222—
+4K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control…Schoelly Fiberoptic GmbH20210—
+4K192704Endofresh Digestive Endoscopy SystemHuizhou Xzing Technology Co., Ltd.20200—
+4K201098Ambu Duodeno SystemAmbu Innovation GmbH20202—
+4K193026Visera Elite II Video System Center, Visera Elite II Endoeye 3DOlympus Medical Systems Corp.20205—
+4K190449Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head…Olympus Medical Systems Corp.20195—
+4K182723Flexible HD Cysto-Urethroscope SystemKARL STORZ Endoscopy-America, Inc.20193—
+4K173921HD-500 Video Endoscope SystemSonoscape Medical Corp.20182—
+4K172726EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433DOlympus Medical Systems Corp.201872
+4K173085invendoscopy E210 SystemInvendo Medical GmbH20180—
+4K161355invendoscopy E200 SystemInvendo Medical GmbH20161—
+4K143727PENTAX Medical EKP-i5010 Video Processor with EB FamilyPentax of America, Inc.20153—
+4K151011Visera 4K Uhd SystemOlympus Medical Systems Corp.20153—
+4K140149Epx-4440HD Digital Video ProcessorFujifilm Medical Systems U.S.A, Inc.201416—
+4K131902Pentax Video Upper G.I. Scopes (EG Family)Pentax Medical Company2014102
+4K131855Pentax Video Colonoscopes (EC Family)Pentax Medical Company2014136
+4K131422Peerscope SystemEndochoice, Inc.20132—
+4K131780Evis Exera Iii Video SystemOlympus Medical Systems Corp.201378
+4K122470Pentax Epk-I5010 Video ProcessorPentax Medical20136—
+4K123365Olympus LTF-190-10-3D, Maj-Y0154, Olympus CV-190Olympus Medical Systems Corp.201319—
+4K122831Video System CenterOlympus Medical Systems Corp.201219—
+4K123317Evis Exera Iii Gastrointestinal Videoscope Olympus GIXP190NOlympus Medical Systems Corporation20120—
+4K113120CHF-Y0005Olympus Medical Systems Corp.20120—
+4K111756V1 SystemOlympus Medical Systems Corp.201202
+4K090814Modification to Gyrus Acmi Invisio Icn, Models Icn-0564 and Icn-0565Gyrus Acmi, Inc.20090—
+4K060269Acmi Dur-Digital Ureteroscope and Choledochoscope SystemAcmi Corporation200699—
+5K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S20260—
+5K261015Solo Scope Colonoscope SystemGi View, Ltd.20260—
+5K261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems Corporation20260—
+5K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker Endoscopy20260—
+5K260695da Vinci Firefly Imaging SystemIntuitive Surgical20260—
+5K260108L12 LED Light Source with AIMStryker Endoscopy20260—
+5K251256PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…Pentax of America, Inc.20250—
+5K2505514K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)Shenzhen Sophway Technology Co., Ltd.20250—
+5K251986Auxiliary Water Tube Maj-855Olympus Medical Systems Corporation20250—
+5K252598Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)Shanghai AnQing Medical Instrument Co., Ltd.20250—
+5K250797UV5000 HandleUroviu Corporation20250—
+5K252176Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K250862Evis Exera Iii Bronchovideoscope (Olympus BF-XP190); Evis Exera Iii Bronchovideoscope…Olympus Medical Systems Corp.20250Class I
+5K250269Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse…Ambu A/S20250—
+5K250957Disposable Biopsy Forceps (FB-211D); Disposable Biopsy Forceps (FB-221D); Disposable…Olympus Medical Systems Corporation20250—
+5K242067Visera Elite Iii Video System Center Olympus Otv-S700; Visera Elite Iii Led Light Source…Olympus Corporations of the Americas20252—
+5K243321Endoscopic Video Image Processor (RP-IPD-V1000F)Guangzhou Red Pine Medical Instrument Co., Ltd.20250—
+5K242110PENTAX Medical Video Colonoscope (EC38-i20cWL)Pentax of America, Inc.20250—
+5K243196Uro-G HD Cystoscope (1520)Uroviu Corporation20240—
+5K241213PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope…Pentax of America, Inc.20240—
+5K241371Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500)Olympus Medical Systems Corporation20240—
+5K233630Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse…Ambu A/S20241—
+5K240283BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR)…MacroLux Medical Technology Co., Ltd.20240—
+5K233886Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2Ambu A/S20241—
+5K232919Ambu® aScope™ Gastro Large; Ambu® aBox™ 2Ambu A/S20241—
+5K2333271788 4K Camera System with Advanced Imaging ModalityStryker Endoscopy20241—
+5K232244Disposable Endoscope Valves SystemChangzhou Endoclean Medical Device Co., Ltd.20230—