Evis Exera II Colonovideoscope
"PCF-Q180AI Evis Exera II Colonoscope"
3manufacturers in China registered for this device type
8catalogue 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 | 2025-11-24 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-07-09 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS PCF TYPE H180AL | In distribution | |
| OLYMPUS PCF TYPE H180AL | Withdrawn | |
| OLYMPUS CF TYPE Q180AL | Withdrawn | |
| OLYMPUS CF TYPE Q180AI | Withdrawn | |
| OLYMPUS PCF TYPE Q180AL | Withdrawn | |
| OLYMPUS PCF TYPE Q180AI | Withdrawn | |
| OLYMPUS PCF TYPE Q180AI | Withdrawn | |
| OLYMPUS PCF TYPE H180AL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SonoScape | Sonoscape Medical Corp. | 10 |
| Medisono | Medisono, LLC | 10 |
| 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 |
| 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
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 | 2024-01-11 | Class II | Nonconforming Material/Component | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads. | 18 |
| Aizu Olympus Co., Ltd. | UDI-DI | 2023-09-25 | Class II | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead t | 3101 units |
| Olympus Corporation of the Americas | UDI-DI | 2022-12-21 | Class II | Process design | A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination | 1 unit |
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.