Single-Use Choledochoscope
6 catalogue numbers from CH-M40, listed by Shenzhen Hugemed Medical Technical Development Co., Ltd., China, under Choledochoscope And Accessories, Flexible/Rigid. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
6catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Shenzhen Hugemed Medical Technical Development Co., Ltd., China |
|---|---|
| FDA product code | FBN |
| Device type | Choledochoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K231497 |
| Record published | 2024-06-11 |
| Record revised | 2025-03-18 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | expiry date, manufacturing date, serial number |
| Packaging | Case of 10, case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CH-M40 | In distribution | |
| CH-M52H | In distribution | |
| CH-M40H | In distribution | |
| CH-M32 | In distribution | |
| CH-M52 | In distribution | |
| CH-M50 | 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 |
| 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 |
| OES Transduodenal Choledochofiberscope | Olympus Medical Systems Corp. | 2 |
Showing 12 of 34. All products under Choledochoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241444 | 2025-01-21 |
| K231497 | 2024-03-06 |
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.