Tangent Digital Catheter
Catalogue number tng-4002-ind, listed by Tangent Endoscopy, LLC, United States, under Choledochoscope And Accessories, Flexible/Rigid. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
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 | Tangent Endoscopy, LLC, United States |
|---|---|
| FDA product code | FBN |
| Device type | Choledochoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K251170 |
| Record published | 2026-04-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| tng-4002-ind | 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 |
|---|---|
| K251170 | 2025-09-12 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Tangent Endoscopy, LLC | 510(k) number | 2026-03-23 | Class II | Process control | Affected devices exhibited fractures at the distal shaft tip without complete detachment. | 53 units |
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.