Choledochoscope And Accessories, Flexible/Rigid
FDA product code FBN · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
to examine and perform procedures within the bile ducts. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
43510(k) clearances
0PMA approvals
9recalls
Manufacturers
- Olympus Medical Systems Corp. 6
- Boston Scientific Corporation 4
- Pentax Precision Instrument Corp. 3
- KARL STORZ Endoscopy-America, Inc. 3
- Shenzhen HugeMed Medical Technical Development Co., Ltd. 2
- Richard Wolf Medical Instruments Corp. 2
- Mirco-Tech (Nanjing) Co., Ltd. 2
- Shanghai SeeGen Photoelectric Technology Co., Ltd. 2
- Applied Laparoscopy 2
- Olympus Corp. 2
- Technology Marketing Group 1
- Fujinon, Inc. 1
- Karl Storz Endoscopy 1
- Olympus America, Inc. 1
- Omega Universal Technologies, Ltd. 1
- Acmi Corporation 1
- Endocure Technologies, Inc. 1
- Micro-Tech (Nanjing) Co., Ltd. 1
- United States Endoscopy Group, Inc. 1
- Zhuhai Pusen Medical Technology Co., Ltd. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254153 | Single-use Video Scope; PB Digital ControllerFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 04/03/2026SE |
| K253139 | Disposable Distal CapFBN · Traditional | Mirco-Tech (Nanjing) Co., Ltd. | 03/19/2026SE |
| K251338 | Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G…FBN · Traditional | Scivita Medical Technology Co., Ltd. | 01/20/2026SE |
| K251170 | Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent…FBN · Traditional | Tangent Endoscopy, LLC | 09/12/2025SE |
| K243535 | Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBN · Special | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 03/07/2025SE |
| K241444 | Biliary Pancreaticobiliary Scope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 01/21/2025SE |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly…FBN · Traditional | CenterPoint Systems, LLC | 05/02/2024SE |
| K231497 | Choledochoscope SystemFBN · Traditional | Shenzhen HugeMed Medical Technical Development… | 03/06/2024SE |
| K231105 | Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US)FBN · Traditional | Shanghai AnQing Medical Instrument Co., Ltd. | 10/17/2023SE |
| K223741 | Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible…FBN · Traditional | Zhuhai Pusen Medical Technology Co., Ltd. | 06/22/2023SE |
| K222261 | Flexible Video-Choledochoscope SystemFBN · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 04/20/2023SE |
| K221784 | Single-use Video Pancreaticobiliary Scope, PB Digital ControllerFBN · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 02/16/2023SE |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital ControllerFBN · Traditional | Boston Scientific Corporation | 05/21/2020SE |
| K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter…FBN · Special | Boston Scientific Corporation | 01/22/2019SE |
| K181439 | SpyGlass DS and DS II Direct Visualization SystemFBN · Special | Boston Scientific Corporation | 08/23/2018SE |
| K161147 | EndoCure Model EUR078AFBN · Traditional | Endocure Technologies, Inc. | 06/07/2016SE |
| K142922 | SpyGlass DS Direct Visualization SystemFBN · Traditional | Boston Scientific Corporation | 01/16/2015SE |
| K113120 | CHF-Y0005FBN · Traditional | Olympus Medical Systems Corp. | 09/25/2012SE |
| K093507 | Olympus CHF Type Y0003FBN · Traditional | Olympus Medical Systems Corporation | 03/10/2010SE |
| K081456 | Olympus CHF Type VFBN · Traditional | Olympus Medical Systems Corporation | 11/06/2008SE |
| K082576 | XCHF-T160 VideoscopeFBN · Traditional | Olympus Medical Systems Corporation | 10/21/2008SE |
| K080586 | Olympus XCHF Type B180Y1FBN · Traditional | Olympus Medical Systems Corporation | 05/06/2008SE |
| K060269 | Acmi Dur-Digital Ureteroscope and Choledochoscope SystemFBN · Traditional | Acmi Corporation | 03/31/2006SE |
| K051886 | Olympus Choledochoscope, Model XCHF-BP160FFBN · Traditional | Olympus Medical Systems Corporation | 11/14/2005SE |
| K972926 | MVM 7.5 French Flexible CholedochoscopeFBN · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/08/1997SE |
| K971977 | Ksea 15.5 Fr. Flexible Choledocho-FiberscopeFBN · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/12/1997SE |
| K962172 | Flexible Mini-FiberscopesFBN · Traditional | Richard Wolf Medical Instruments Corp. | 12/02/1996SE |
| K944473 | XCHF-33 CholedochofiberscopeFBN · Traditional | Olympus America, Inc. | 11/22/1995SE |
| K953286 | FCP-9P, Fiber CholedochoscopeFBN · Traditional | Pentax Precision Instrument Corp. | 11/03/1995SE |
| K951191 | FCN-15X, Fiber CholedochonephroscopeFBN · Traditional | Pentax Precision Instrument Corp. | 05/30/1995SE |
| K942112 | Karl Storz Flexible CholedochoscopeFBN · Traditional | Karl Storz Endoscopy | 02/28/1995SE |
| K933906 | Choledochoscope/Endoscope ModificationFBN · Traditional | Fujinon, Inc. | 07/08/1994SE |
| K935834 | TAS-211/2.3 Ultrathin Flexible EndoscopeFBN · Traditional | Technology Marketing Group | 03/07/1994SE |
| K931382 | 11274 Ac Flexinble CholedochoscopeFBN · Traditional | KARL STORZ Endoscopy-America, Inc. | 06/18/1993SE |
| K924228 | OmegascopeFBN · Traditional | Omega Universal Technologies, Ltd. | 02/26/1993SE |
| K920224 | Doscope and AcessoriesFBN · Traditional | Applied Laparoscopy | 08/21/1992SESK |
| K915681 | CholedochoscopeFBN · Traditional | Applied Laparoscopy | 01/30/1992SE |
| K912120 | URF-P2 Ureterorenofiberscope/CholedochofiberscopeFBN · Traditional | Olympus Corp. | 08/07/1991SE |
| K911480 | Flexible CholedochoscopeFBN · Traditional | United States Endoscopy Group, Inc. | 06/20/1991SE |
| K904799 | CHF-B20 CholedochoscopeFBN · Traditional | Olympus Corp. | 03/27/1991SE |
| K901010 | Flexible CholedochoscopeFBN · Traditional | Intramed Laboratories, Inc. | 05/22/1990SE |
| K821974 | Pentax Choledochofiberscope, #FCD-15AFBN · Traditional | Pentax Precision Instrument Corp. | 08/10/1982SE |
| K771367 | Choledochoscope SystemFBN · Traditional | Richard Wolf Medical Instruments Corp. | 08/02/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2209-2026 Class II | Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) TNG4002-IND.…Affected devices exhibited fractures at the distal shaft tip without complete detachment. | Tangent Endoscopy, LLC | 03/23/2026Open, Classified |
| Z-0905-2025 Class I | Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891.…Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as… | Olympus Corporation of the Americas | 12/18/2024Open, Classified |
| Z-0345-2024 Class II | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle…Channel air drying process was not validated, and that a small percentage of scopes returned to customers… | Aizu Olympus Co., Ltd. | 09/25/2023Open, Classified |
| Z-1122-2022 Class II | Olympus DISPOSABLE GRASPING FORCEPS, FG-51DForceps do not comply with Olympus standards for the amount of force required to open and close the forceps | Olympus Corporation of the Americas | 03/31/2022Terminated |
| Z-0119-2021 Class II | Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be used with an…The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with… | Olympus Corporation of the Americas | 08/31/2020Terminated |
| Z-1133-2018 Class II | SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result… | Boston Scientific Corporation | 12/20/2017Terminated |
| Z-1251-2017 Class II | URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscopeOlympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not… | Olympus Corporation of the Americas | 12/12/2016Terminated |
| Z-2067-2016 Class II | Choledochoscope Intended to provide optical visualization of and therapeutic access to…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |
| Z-2066-2016 Class II | Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic…Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents… | Pentax Medical Company | 04/06/2016Terminated |