Home › Device types › FBN
Choledochoscope And Accessories, Flexible/Rigid
FDA product code FBN · Class 2 · Gastroenterology, Urology
84
Registered devices
2,300
Adverse events
9
Recalls
43
510(k) clearances
Devices with this code
OES URETERO-RENO FIBERSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.OES TRANSDUODENAL CHOLEDOCHOFIBERSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Flexible Video-Choledo-Cysto-Ureteroscope — Shanghai SeeGen Photoelectric Technology Co., LtdFlexible Video-Choledo-Cysto-Ureteroscope — Shanghai SeeGen Photoelectric Technology Co., LtdSingle-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd.GAS TUBE — OLYMPUS MEDICAL SYSTEMS CORP.SpyGlass™ Discover — BOSTON SCIENTIFIC CORPORATIONFlexible Video-Choledochoscope — Shanghai SeeGen Photoelectric Technology Co., LtdWiScope® — Otu Medical Inc.PENTAX — HOYA CORPORATIONBiopsy Valve — OLYMPUS MEDICAL SYSTEMS CORP.PENTAX — HOYA CORPORATIONFlexible Video-Choledochoscope — Shanghai SeeGen Photoelectric Technology Co., LtdURETERO-RENO VIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Forceps Suction Plug (T-Plug) — OLYMPUS MEDICAL SYSTEMS CORP.URETERO-RENO FIBERSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.Forcepts/Irrigation Plug — OLYMPUS MEDICAL SYSTEMS CORP.SpyScope™ DS II — BOSTON SCIENTIFIC CORPORATIONDISPOSABLE GRASPING FORCEPS (BASKET TYPE) — OLYMPUS MEDICAL SYSTEMS CORP.INVISIO — Gyrus ACMI, LLCSingle-Use Choledochoscope — Shenzhen HugeMed Medical Technical Development Co., Ltd.Innovex — Shanghai AnQing Medical Instrument Co., LtdFIBER PANCREATOSCOPE — PENTAX OF AMERICA, INC.EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE — OLYMPUS MEDICAL SYSTEMS CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-23 | TANGENT ENDOSCOPY, LLC | Affected devices exhibited fractures at the distal shaft tip without complete detachment. |
| 2024-12-18 | Olympus Corporation of the Americas | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembli |
| 2023-09-25 | Aizu Olympus Co., Ltd. | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the |
| 2022-03-31 | Olympus Corporation of the Americas | Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps |
| 2020-08-31 | Olympus Corporation of the Americas | The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of meta |
| 2017-12-20 | Boston Scientific Corporation | Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant |
| 2016-12-12 | Olympus Corporation of the Americas | Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's |
| 2016-04-06 | Pentax Medical Company | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's |
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