Forceps/Irrigation Plug (Isolated Type)
"MAJ-891 Forceps/Irrigation Plug Isolated"
8manufacturers in China registered for this device type
1catalogue number
6510(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 | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FBN |
| Device type | Choledochoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2024-07-25 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, High-level Disinfectant, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-04-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAJ-891 | Withdrawn |
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 |
|---|---|
| K113120 | 2012-09-25 |
| K093507 | 2010-03-10 |
| K081456 | 2008-11-06 |
| K082576 | 2008-10-21 |
| K080586 | 2008-05-06 |
| K051886 | 2005-11-14 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2024-12-18 | Class I | Labeling design | Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device. | 30,140 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.