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 |
| K964482 | APPLIED FIBEROPTICS, INC. | FLEXIBLE URETEROSCOPE | 01/24/1997 |
| K213334 | Auris Health Inc | Monarch Platform, Urology | 04/29/2022 |
| 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 |
| 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 |
| K000200 | CORTEK ENDOSCOPY, INC. | CORTEK URETHEROSCOPE | 03/03/2000 |
| 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 |
| K230200 | Hunan Vathin Medical Instrument Co., Ltd. | Single-Use Flexible Ureteroscope | 05/18/2023 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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