CholangioFlex™ N
The filing names CholangioFlex™ N as a Cellvizio I.V.E. confocal miniprobe. Its stated role is imaging the upper gastrointestinal tract including biliary and pancreatic ducts. The filing…
The filing names CholangioFlex™ N as a Cellvizio I.V.E. confocal miniprobe. Its stated role is imaging the upper gastrointestinal tract including biliary and pancreatic ducts.
The filing describes the overall system as a confocal laser system with fiber-optic probes for imaging internal tissue microstructure, including cells and vessels and their organization.
Access Route
The listed probe is intended to access its named tract through an endoscope or endoscopic accessories.
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Mauna KEA Technologies, France |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Manufacturer |
| 510(k) | K193416 |
| Record published | 2020-05-15 |
| Record revised | 2021-07-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FP-10035 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VS3-IR | Visionsense, Ltd. | 22 |
| Confocal Microprobe Imaging System | Wuxi Hisky Medical Technologies Co., Ltd. | 16 |
| Confocal Optical Imaging | Karl Storz GmbH & Co. KG | 13 |
| Hopkins | Karl Storz GmbH & Co. KG | 4 |
| AIM (Advanced Imaging Modality) | Stryker GmbH | 4 |
| VS3-NE | Visionsense, Ltd. | 3 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 2 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220477 | 2022-04-11 |
| K212322 | 2021-08-18 |
| K193416 | 2020-02-28 |
| K191144 | 2020-01-24 |
| K183640 | 2019-02-22 |
| K172844 | 2017-12-15 |
| K171345 | 2017-08-04 |
| K160416 | 2016-05-20 |
| K150831 | 2015-12-22 |
| K151593 | 2015-10-23 |
| K141358 | 2014-09-25 |
| K133466 | 2014-07-25 |
| K123676 | 2013-04-18 |
| K122042 | 2012-09-04 |
| K120208 | 2012-04-20 |
| K111047 | 2011-08-08 |
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.