FDA 510(k) Applications for Medical Device Product Code "FGB"
(Ureteroscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K052044 | ACMI CORPORATION | ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL | 08/16/2005 |
| K023358 | ACMI CORPORATION | USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 | 01/03/2003 |
| K233630 | Ambu A/S | Ambu« aScopeÖ 5 Uretero (Standard Deflection); Ambu« aScopeÖ 5 Uretero (Reverse Deflection); Ambu« aBoxÖ 2 | 06/24/2024 |
| K242108 | Ambu A/S | Ambu« aScopeÖ 5 Uretero (Standard Deflection); Ambu« aScopeÖ 5 Uretero (Reverse Deflection); Ambu« aViewÖ 2 Advance | 08/16/2024 |
| K964482 | APPLIED FIBEROPTICS, INC. | FLEXIBLE URETEROSCOPE | 01/24/1997 |
| K213334 | Auris Health Inc | Monarch Platform, Urology | 04/29/2022 |
| K241598 | Boston Scientific Corporation | LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope -û Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital F | 07/01/2024 |
| K153049 | BOSTON SCIENTIFIC CORPORATION | LithoVue System | 11/13/2015 |
| K221515 | Boston Scientific Corporation | StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring | 02/02/2023 |
| K233645 | Boston Scientific Corporation - | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection | 12/12/2023 |
| K223097 | CenterPoint Systems LLC | RenaNav Ureteroscope System | 07/31/2023 |
| K012951 | CIRCON VIDEO | APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE | 11/09/2001 |
| K012925 | CIRCON VIDEO | DUR-8, MODELS DUR-8 | 11/07/2001 |
| K011849 | CIRCON VIDEO | MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROS | 12/10/2001 |
| K012758 | CIRCON VIDEO | URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L, | 04/09/2002 |
| K243532 | Contra Healthcare Solutions, LLC | LumiRex Ureteroscope | 04/28/2025 |
| K000200 | CORTEK ENDOSCOPY, INC. | CORTEK URETHEROSCOPE | 03/03/2000 |
| K243155 | Dongguan ZSR Biomedical technology Company Limited | Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) | 02/11/2025 |
| K240203 | DYNE Medical Group Inc. | URUS System (DMG-SU100/URUS); URUS System (DMG-SU100R/URUS); URUS System (VP-100/Video Processor) | 09/05/2024 |
| K233700 | Elmed Elektronik ve Medikal Sanayi ve Ticaret Anonim Sirketi | Avicenna Roboflex | 08/16/2024 |
| K992527 | FIBER IMAGING TECHNOLOGIES, INC. | URETERO-RENOSCOPE | 10/13/1999 |
| K003806 | GLOBAL ENDOSCOPY, INC. | URETEROSCOPES | 02/22/2001 |
| K221158 | Guangzhou Red Pine Medical Instrument Co., Ltd. | Single-Use Video Flexible Ureterorenoscope System | 03/06/2023 |
| K233275 | Gyrus ACMI, Inc | RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) | 03/25/2024 |
| K230475 | HUGER Medical Instrument Co., Ltd. | Medical Video Endoscope System | 11/03/2023 |
| K241639 | HUGER Medical Instrument Co., Ltd. | Single-use Video Ureterorenoscope (SVU-220US) | 07/01/2024 |
| K241956 | Hunan Endoso Life Technology Co., Ltd. | Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) | 01/22/2025 |
| K243117 | Hunan Vathin Medical Instrument Co., Ltd, | Digital Video Processor | 01/29/2025 |
| K230200 | Hunan Vathin Medical Instrument Co., Ltd. | Single-Use Flexible Ureteroscope | 05/18/2023 |
| K231135 | Hunan Vathin Medical Instrument Co., Ltd. | Video Ureteroscope System | 01/17/2024 |
| K241434 | Hunan Vathin Medical Instrument Co., Ltd. | Video Ureteroscope System | 10/04/2024 |
| K250785 | Hunan Vathin Medical Instrument Co.Ltd | Single-use Flexible Ureteroscope | 05/06/2025 |
| K062707 | INNOVATIVE ENDOSCOPY COMPONENTS, LLC. | RUDOLF INNOVIEW AUTOCLAVABLE SEMI-RIGID URETERO-RENOSCOPE | 12/08/2006 |
| K970427 | KARL STORZ ENDOSCOPY | KSEA URETERO-RENO-FIBERSCOPE AND NEPHRO-FIBERSCOPE | 03/11/1997 |
| K982905 | KARL STORZ ENDOSCOPY | MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE | 10/05/1998 |
| K212458 | KARL STORZ Endoscopy America | Flexible Video-Uretero-Renoscope SSU System | 01/20/2022 |
| K142556 | KARL STORZ ENDOSCOPY-AMERICA, INC. | Flexible Video-Uretero-Choledochoscope System | 10/23/2014 |
| K131369 | KARL STORZ ENDOSCOPY-AMERICA, INC. | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | 11/26/2013 |
| K141250 | KARL STORZ ENDOSCOPY-AMERICA, INC. | FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM | 06/11/2014 |
| K960323 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE | 04/22/1996 |
| K232911 | Karl Storz Endovision, Inc | KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) | 06/10/2024 |
| K233372 | Karl Storz SE & Co. Kg | KARL STORZ Fiber Telescopes for Urology | 07/25/2024 |
| K243550 | KARL STORZ SE & CO. KG | KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) | 06/06/2025 |
| K241945 | KARL STORZ SE & CO. KG | KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) | 08/01/2024 |
| K231774 | MacroLux Medical Technology Co., Ltd. | CoralView« Single-use Digital Flexible Ureteroscope (U10); CoralView« Single-use Digital Flexible Ureteroscope (U10-B); CoralView« Single-use Digital Flexible Ureteroscope (U10-BR); CoralView« Single-use Digital Flexible Ureteroscope (U20); CoralView« Sin | 01/11/2024 |
| K011325 | MEDIFIX, INC. | MEDIFIX URETEROSCOPE | 07/25/2001 |
| K172298 | Olympus Medical Systems Corp. | OLYMPUS URF-P6/P6R | 03/29/2018 |
| K172246 | Olympus Medical Systems Corp. | OLYMPUS URF-V2/V2R | 03/30/2018 |
| K181451 | Olympus Medical Systems Corp. | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R | 01/16/2019 |
| K200369 | Olympus Winter & Ibe GmbH | OES Elite Ureteroscopes and Accessories | 08/28/2020 |
| K033651 | OLYMPUS WINTER & IBE GMBH | OLYMPUS VIDEO URETEROSCOPE, NTSC | 01/30/2004 |
| K242699 | Opcom Medical Inc. | Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) | 05/28/2025 |
| K181977 | OTU Medical Inc. | WiScope Digital Endoscope System | 08/14/2018 |
| K210579 | OTU Medical Inc. | WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System | 07/22/2021 |
| K963855 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | 12 URETEROSCOPES/URETERO-RENOSCOPES | 04/03/1997 |
| K991178 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 | 06/11/1999 |
| K990050 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 | 03/26/1999 |
| K183188 | Richard Wolf Medical Instruments Corporation | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | 05/03/2019 |
| K201897 | Richard Wolf Medical Instruments Corporation | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | 01/15/2021 |
| K243708 | Scivita Medical Technology Co., Ltd. | Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P;Single-use Flexible Cystoscope: SUV-1D-B, SUV-1D-P; Endoscopic Image Processor: HDVS-S100A, HDVS-S100D.) | 03/27/2025 |
| K243894 | SG Endoscopy Pte Ltd | F88 URE-SD/RD Flexible Ureteroscope | 05/02/2025 |
| K220159 | Shanghai AnQing Medical Instrument Co., Ltd. | Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) | 08/26/2022 |
| K222737 | Shanghai AnQing Medical Instrument Co., Ltd. | Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) | 10/05/2022 |
| K243857 | Shanghai AnQing Medical Instrument Co., Ltd. | Flexible Ureterorenoscope (US27F-12-EU; US27F-12-US) | 04/11/2025 |
| K180367 | Shanghai AnQing Medical Instrument CO., Ltd. | Ureterorenoscope System | 07/03/2018 |
| K201293 | Shanghai AnQing Medical Instrument Co., Ltd. | Ureterorenoscope System | 07/24/2020 |
| K211686 | Shanghai SeeGen Photoelectric Technology Co., Ltd | Flexible Video-Choledo-Cysto-Ureteroscope System | 02/22/2022 |
| K240074 | Shenzhen Besdata Technology Co., Ltd. | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | 10/04/2024 |
| K240374 | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Ureterorenoscope System | 05/10/2024 |
| K231878 | STERIS Corporation | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 | 07/25/2023 |
| K223466 | Steris Corporation | Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 | 02/17/2023 |
| K211347 | STERIS Corporation | Uretero1 Ureteroscope System | 11/23/2021 |
| K031278 | Stryker Endoscopy | STRYKER FLEXIBLE URETEROSCOPE | 10/16/2003 |
| K043021 | Stryker Endoscopy | STRYKER URETEROSCOPE | 03/16/2005 |
| K121112 | Stryker Endoscopy | STRYKER VIDEO URETEROSCOPE | 09/12/2012 |
| K111480 | TECHNOLOGY DELIVERY SYSTEMS, INC. | MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM | 04/04/2012 |
| K062725 | TECHNOLOGY DELIVERY SYSTEMS, INC. | MAXIFLEX-SEMI FLEX SCOPE | 09/29/2006 |
| K171076 | Zhuhai Pusen Medical Technology Co., Ltd. | Medical Video Endoscope System | 05/05/2017 |
| K172098 | Zhuhai Pusen Medical Technology Co., Ltd. | Medical Video Endoscope System | 08/31/2017 |
| K233778 | Zhuhai Pusen Medical Technology Co., Ltd. | Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) | 07/16/2024 |
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