Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps
The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope for viewing the pancreatic and biliary ducts, including hepatic ducts. It passes through a duodenoscope and…
The Dragonfly Pancreaticobiliary Scope is a sterile, single-use endoscope for viewing the pancreatic and biliary ducts, including hepatic ducts. It passes through a duodenoscope and provides access for optical and accessory devices during diagnostic and therapeutic procedures in this anatomy.
The scope combines a handle, catheter, camera, illumination elements and video connection. Deflection knobs steer its tip. A separate reusable Dragonfly Digital Controller supplies illumination power and receives, processes and outputs the scope’s images. The scope has a 139 cm working length and a 5.1 Fr working channel.
Listed Item
Single use pancreaticobiliary scope
Included Channel Caps
Instrument-channel caps cover the biopsy/suction inlet of compatible Olympus, Fujifilm or Pentax duodenoscopes. They are exclusively for Dragonfly scope passage, maintaining insufflation and limiting biomaterial leakage from the biopsy port during the procedure. The scope uses LED illumination and a CMOS image sensor.
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Wise Optomech Technology Corporation | Ningbo | Zhejiang | Contract manufacturer | 4 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Eternal (Shanghai) Medical Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 7 |
| Shenzhen Besdata Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Shanghai AnQing Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
Record
| Listed by | Centerpoint Systems LLC, United States |
|---|---|
| FDA product code | FBN |
| Device type | Choledochoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K233752 |
| Record published | 2024-07-22 |
| Record revised | 2025-03-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DFE-MD-000652 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Single-use Video Scope | Micro-Tech (Nanjing) Co., Ltd. | 24 |
| Choledochoscope And Accessories, Flexible/Rigid | Richard Wolf Gmbh | 8 |
| Single-Use Choledochoscope | Shenzhen Hugemed Medical Technical Development Co., Ltd. | 6 |
| Pentax | Hoya Corporation | 5 |
| Flexible Video-Choledo-Cysto-Ureteroscope | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 5 |
| Riwo | Richard Wolf Gmbh | 4 |
| Flexible Video-Choledochoscope | Shanghai SeeGen Photoelectric Technology Co., Ltd. (YinDu Road Factory) | 4 |
| WiScope® | OTU Medical Inc | 4 |
| Choledochoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 4 |
| OES Uretero-Reno Fiberscope | Olympus Medical Systems Corp. | 3 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 3 |
| Fiber Pancreatoscope | Pentax of America, Inc. | 2 |
Showing 12 of 34. All products under Choledochoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233752 | 2024-05-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.