Devices descending from K981543
431 later devices reach Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +7 | K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 | Fujifilm Corporation | 2026 | 0 | — |
| +7 | K252492 | Visualized Access and Delivery Catheter; PB Digital Controller | Micro-Tech (Nanjing) Co., Ltd. | 2026 | 0 | — |
| +7 | K252468 | Single-use Digital Flexible Ureteroscope (GY-UR9.3); Single-use Digital Flexible… | Zhejiang Geyi Medical Instrument Co., Ltd. | 2025 | 0 | — |
| +7 | K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025 | 1 | — |
| +7 | K250049 | Medical Video Endoscope [Standard Deflection] (URS3005); Medical Video Endoscope… | Seplou (Zhuhai) Co., Ltd. | 2025 | 0 | — |
| +7 | K250900 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025 | 0 | — |
| +7 | K243550 | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | Karl Storz SE & CO. KG | 2025 | 0 | — |
| +7 | K250785 | Single-use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2025 | 0 | — |
| +7 | K243894 | F88 URE-SD/RD Flexible Ureteroscope | Sg Endoscopy Pte, Ltd. | 2025 | 0 | — |
| +7 | K243532 | LumiRex Ureteroscope | Contra Healthcare Solutions, LLC | 2025 | 0 | — |
| +7 | K243708 | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P… | Scivita Medical Technology Co., Ltd. | 2025 | 1 | — |
| +7 | K243380 | Visera S Video System Center Olympus Otv-S500 (Olympus Otv-S500) | Olympus Medical Systems Corporation | 2025 | 0 | — |
| +7 | K241532 | Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 2024 | 0 | — |
| +7 | K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2)… | Shenzhen Besdata Technology Co., Ltd. | 2024 | 0 | — |
| +7 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | 0 | — |
| +7 | K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor… | Pentax of America, Inc. | 2024 | 0 | — |
| +7 | K233778 | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video… | Zhuhai Pusen Medical Technology Co., Ltd. | 2024 | 1 | — |
| +7 | K241598 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure… | Boston Scientific Corporation | 2024 | 1 | — |
| +7 | K233752 | Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™… | CenterPoint Systems, LLC | 2024 | 0 | — |
| +7 | K233472 | CVAC Aspiration System + CVAC Image Processor | Calyxo, Inc. | 2024 | 3 | Class I |
| +7 | K231135 | Video Ureteroscope System | Hunan Vathin Medical Instrument Co., Ltd. | 2024 | 1 | — |
| +7 | K231774 | CoralView® Single-use Digital Flexible Ureteroscope (U10); CoralView® Single-use Digital… | MacroLux Medical Technology Co., Ltd. | 2024 | 0 | — |
| +7 | K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse… | Boston Scientific Corporation - | 2023 | 3 | 1 |
| +7 | K230475 | Medical Video Endoscope System | Huger Medical Instrument Co., Ltd. | 2023 | 2 | — |
| +7 | K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible… | Zhuhai Pusen Medical Technology Co., Ltd. | 2023 | 0 | — |
| +7 | K230200 | Single-Use Flexible Ureteroscope | Hunan Vathin Medical Instrument Co., Ltd. | 2023 | 2 | — |
| +7 | K221158 | Single-Use Video Flexible Ureterorenoscope System | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2023 | 3 | — |
| +7 | K223759 | Arthrex SynergyID Endoscopic Imaging System | Arthex, Inc. | 2023 | 4 | — |
| +7 | K223466 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101… | STERIS Corporation | 2023 | 2 | — |
| +7 | K223127 | HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable | Edwards Lifeciences, LLC | 2022 | 6 | — |
| +7 | K212458 | Flexible Video-Uretero-Renoscope SSU System | Karl Storz Endoscopy America | 2022 | 0 | — |
| +7 | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 | Fujifilm Corporaton | 2021 | 3 | — |
| +7 | K203490 | FORE-SIGHT ELITE Absolute Tissue Oximeter | Edwards Lifesciences, LLC | 2021 | 0 | 1 |
| +7 | K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | Richard Wolf Medical Instruments Corporation | 2021 | 0 | — |
| +7 | K202469 | G-EYE System | Smart Medical Systems, Ltd. | 2020 | 1 | — |
| +7 | K202130 | FUJIFILM Video Laparoscope | Fujifilm Corporation | 2020 | 1 | — |
| +7 | K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2020 | 4 | — |
| +7 | K193007 | LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording… | Lina Medical Aps | 2020 | 0 | — |
| +7 | K190205 | HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module | Edwards Lifesciences, LLC | 2019 | 34 | — |
| +7 | K182429 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2019 | 3 | — |
| +7 | K181545 | Hysteroscope System | Shanghai AnQing Medical Instrument Co., Ltd. | 2019 | 2 | — |
| +7 | K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter… | Boston Scientific Corporation | 2019 | 5 | — |
| +7 | K181977 | WiScope Digital Endoscope System | OTU Medical, Inc. | 2018 | 3 | — |
| +7 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter | Cas Medical Systems, Inc. | 2018 | 29 | 1 |
| +7 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | 5 | — |
| +7 | K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017 | 0 | — |
| +7 | K132384 | U-Scope 8000 System with HSC+Emb Cannula | Endosec Corporation | 2014 | 19 | — |
| +8 | K261447 | CVAC® Aspiration System | Calyxo, Inc. | 2026 | 0 | — |
| +8 | K261153 | LithoVue Elite Digital Flexible Ureteroscope System | Boston Scientific Corporation | 2026 | 0 | — |
| +8 | K262552 | Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B) | Scivita Medical Technology Co., Ltd. | 2026 | 0 | — |
| +8 | K260573 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2026 | 0 | — |
| +8 | K260965 | CVAC Aspiration System | Calyxo, Inc. | 2026 | 0 | — |
| +8 | K252929 | Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model… | Anhui Happiness Workshop Instruments Co., Ltd. | 2026 | 0 | — |
| +8 | K260013 | CVAC Image Processor | Calyxo, Inc. | 2026 | 0 | — |
| +8 | K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G… | Scivita Medical Technology Co., Ltd. | 2026 | 0 | — |
| +8 | K251951 | Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2025 | 1 | — |
| +8 | K250917 | Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model… | Shenzhen Sanping Image Technology Co., Ltd. | 2025 | 0 | — |
| +8 | K252703 | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure… | Boston Scientific Corporation | 2025 | 0 | — |
| +8 | K250268 | HyperSnap Surgical System (HSS) | Hypervision Surgical | 2025 | 1 | — |
| +8 | K243155 | Single-Use Digital Flexible Ureteroscope (F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03… | Dongguan Zsr Biomedical Technology Company Limited | 2025 | 0 | — |
| +8 | K243117 | Digital Video Processor | Hunan Vathin Medical Instrument Co., Ltd. | 2025 | 0 | — |
| +8 | K241956 | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5… | Hunan Endoso Life Technology Co., Ltd. | 2025 | 0 | — |
| +8 | K240203 | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video… | Dyne Medical Group, Inc. | 2024 | 0 | — |
| +8 | K241639 | Single-use Video Ureterorenoscope (SVU-220US) | Huger Medical Instrument Co., Ltd. | 2024 | 0 | — |
| +8 | K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head… | Schoelly Fiberoptic GmbH | 2024 | 0 | — |
| +8 | K240374 | Ureterorenoscope System | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2024 | 0 | — |
| +8 | K233451 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | 3 | — |
| +8 | K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Edwards Lifesciences, LLC | 2023 | 5 | — |
| +8 | K231878 | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101… | STERIS Corporation | 2023 | 1 | — |
| +8 | K220159 | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model… | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | 3 | — |
| +8 | K220158 | G-EYE System | Smart Medical Systems, Ltd. | 2022 | 0 | — |
| +8 | K212950 | FUJIFILM Video Laparoscope EL-R740M30 | Fujifilm Corporaton | 2021 | 0 | — |
| +8 | K202445 | Hystero-V Hysteroscope | Hysterovue, Inc. | 2021 | 4 | — |
| +8 | K210270 | Medical Endoscope Image Processing System | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2021 | 1 | — |
| +8 | K203131 | EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform | Edwards Lifesciences, LLC | 2021 | 0 | — |
| +8 | K200717 | CLEWICU System (ClewICUServer and ClewICUnitor) | Clew Medical, Ltd. | 2021 | 12 | — |
| +8 | K201446 | HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module | Edwards Lifesiences, LLC | 2020 | 27 | 1 |
| +8 | K201432 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2020 | 2 | — |
| +8 | K190797 | Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) | Reed Medical (Zhejiang) Co., Ltd. | 2019 | 0 | — |
| +8 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module | Cas Medical Systems, Inc. | 2019 | 15 | — |
| +8 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 4 | 1 |
| +8 | K151275 | MAKO Device | Nvision Medical | 2015 | 2 | — |
| +9 | K262488 | Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9… | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2026 | 0 | — |
| +9 | K253984 | Instrument Exit Point on Touch Surgery™ Aide | Covidien, LLC | 2026 | 0 | — |
| +9 | K252793 | ARMI® Endoscopic Video Image Processor (JY-MIP-3000); ARMI® Single-Use Hysteroscope… | Jiangsu Jiyuan Medical Technology Co., Ltd. | 2025 | 0 | — |
| +9 | K242699 | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope… | Opcom Medical, Inc. | 2025 | 0 | — |
| +9 | K243857 | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2025 | 1 | — |
| +9 | K242451 | HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta-… | Edwards Lifesciences | 2024 | 4 | — |
| +9 | K241361 | Arthrex Synergy Vision Endoscopic Imaging System | Arthrex, Inc. | 2024 | 2 | — |
| +9 | K233253 | eCARTv5 Clinical Deterioration Suite (“eCART”) | Agilemd, Inc. | 2024 | 1 | — |
| +9 | K232003 | Endoscopic Video Image Processor, Single-Use Video Hysteroscope | Guangzhou Red Pine Medical Instrument Co., Ltd. | 2024 | 3 | — |
| +9 | K233216 | CLEWICU System | Clew Medical, Ltd. | 2024 | 0 | — |
| +9 | K231038 | Global Hypoperfusion Index (GHI) Algorithm | Edwards Lifesciences, LLC | 2023 | 6 | — |
| +9 | K221833 | HemoSphere Advanced Monitor, HemoSphere ClearSight Module | Edwards Lifesciences, LLC | 2022 | 7 | — |
| +9 | K222737 | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | Shanghai AnQing Medical Instrument Co., Ltd. | 2022 | 0 | — |
| +9 | K213682 | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable… | Edwards Lifesciences, LLC | 2022 | 14 | — |
| +9 | K214072 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2022 | 1 | — |
| +9 | K212219 | AHI System | Fifth Eye, Inc. | 2021 | 1 | — |
| +9 | K203224 | Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform | Edwards Lifesciences, LLC | 2021 | 1 | — |
| +9 | K211465 | HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform | Edwards Lfesciences | 2021 | 15 | — |