Visera Cysto-Nephro Videoscope
CYF-VA2 Flex CystoNephro Videoscope wAsp
3manufacturers in China registered for this device type
6catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1), Shandong (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 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | NWB |
| Device type | Endoscope, Accessories, Narrow Band Spectrum |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2024-06-19 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, High-level Disinfectant |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-01-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS CYF- TYPE VA2 | In distribution | |
| OLYMPUS CYF- TYPE VA2 | In distribution | |
| OLYMPUS CYF TYPE V2R | Withdrawn | |
| OLYMPUS CYF TYPE V2R | Withdrawn | |
| OLYMPUS CYF TYPE V2 | Withdrawn | |
| OLYMPUS CYF TYPE V2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 10 |
| Medisono | Medisono, LLC | 10 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 8 |
| Rhino-Laryngo Videoscope | Olympus Medical Systems Corp. | 7 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 7 |
| Uretero-Reno Videoscope | Olympus Medical Systems Corp. | 4 |
| Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 4 |
| Olympus | Olympus Winter & IBE Gmbh | 4 |
| Foot Holder | Olympus Medical Systems Corp. | 3 |
| Light source cable | Olympus Medical Systems Corp. | 3 |
| Foot Switch | Olympus Medical Systems Corp. | 3 |
| Evis Exera II Duodenovideoscope | Olympus Medical Systems Corp. | 3 |
Showing 12 of 66. All products under Endoscope, Accessories, Narrow Band Spectrum
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100584 | 2010-07-02 |
| K072957 | 2008-03-18 |
| K062049 | 2006-09-22 |
| K051645 | 2005-10-13 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Shirakawa Olympus Co., Ltd. | UDI-DI | 2023-12-04 | Class II | Under Investigation by firm | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | 2210 US; 6002 OUS |
| Shirakawa Olympus Co., Ltd. | UDI-DI | 2023-12-04 | Class II | Under Investigation by firm | Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible. | 608 US; 1264 OUS |
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.