FDA 510(k) Applications for Medical Device Product Code "FBN"
(Choledochoscope And Accessories, Flexible/Rigid)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K060269 | ACMI CORPORATION | ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM | 03/31/2006 |
| K200483 | Boston Scientific Corporation | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | 05/21/2020 |
| K181439 | Boston Scientific Corporation | SpyGlass DS and DS II Direct Visualization System | 08/23/2018 |
| K142922 | BOSTON SCIENTIFIC CORPORATION | SpyGlass DS Direct Visualization System | 01/16/2015 |
| K183636 | Boston Scientific Corporation | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | 01/22/2019 |
| K233752 | CenterPoint Systems LLC | DragonflyÖ Pancreaticobiliary Scope; DragonflyÖ Digital Controller; DragonflyÖ Instrument Channel Caps | 05/02/2024 |
| K161147 | ENDOCURE TECHNOLOGIES, INC. | EndoCure Model EUR078A | 06/07/2016 |
| K971977 | KARL STORZ ENDOSCOPY-AMERICA, INC. | KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE | 08/12/1997 |
| K972926 | KARL STORZ ENDOSCOPY-AMERICA, INC. | MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE | 10/08/1997 |
| K221784 | Micro-Tech (Nanjing) Co., Ltd | Single-use Video Pancreaticobiliary Scope, PB Digital Controller | 02/16/2023 |
| K113120 | OLYMPUS MEDICAL SYSTEMS CORP. | CHF-Y0005 | 09/25/2012 |
| K081456 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS CHF TYPE V | 11/06/2008 |
| K093507 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS CHF TYPE Y0003 | 03/10/2010 |
| K051886 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F | 11/14/2005 |
| K080586 | OLYMPUS MEDICAL SYSTEMS CORPORATION | OLYMPUS XCHF TYPE B180Y1 | 05/06/2008 |
| K082576 | OLYMPUS MEDICAL SYSTEMS CORPORATION | XCHF-T160 VIDEOSCOPE | 10/21/2008 |
| K962172 | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FLEXIBLE MINI-FIBERSCOPES | 12/02/1996 |
| K231105 | Shanghai AnQing Medical Instrument Co., Ltd | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) | 10/17/2023 |
| K222261 | Shanghai SeeGen Photoelectric Technology Co., Ltd | Flexible Video-Choledochoscope System | 04/20/2023 |
| K243535 | Shanghai SeeGen Photoelectric Technology Co., Ltd. | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U) | 03/07/2025 |
| K231497 | Shenzhen HugeMed Medical Technical Development Co., Ltd | Choledochoscope System | 03/06/2024 |
| K241444 | Shenzhen HugeMed Medical Technical Development Co., Ltd. | Biliary Pancreaticobiliary Scope System | 01/21/2025 |
| K223741 | Zhuhai Pusen Medical Technology Co., Ltd. | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R;HD Medical Video Endoscope Image Processor: PV300) | 06/22/2023 |
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