Evis Exera II Bronchovideoscope
BF-P180 Videoscope 4.9MM DIA 2.0MM CH
3manufacturers in China registered for this device type
1catalogue number
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 | 2024-01-12 (version 6) |
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 |
|---|---|---|
| OLYPUS BF TYPE P180 | Withdrawn |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 |
| Visera Cysto-Nephro Videoscope | Olympus Medical Systems Corp. | 6 |
| 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 |
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
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | UDI-DI | 2023-07-27 | Class II | Labeling Change Control | Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | 3652 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-06-08 | Class I | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | 1535 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-06-08 | Class I | Under Investigation by firm | There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | 17,609 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.