Evis Exera Colonovideoscope
CF-2T160L Therapeutic Video Colonoscope
8manufacturers in China registered for this device type
5catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Zhuhai Pusen Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FET |
| Device type | Endoscopic Video Imaging System/Component, Gastroenterology-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-21 |
| Record revised | 2023-01-16 (version 6) |
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 | 2024-01-11 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS CF TYPE 2T160L | Withdrawn | |
| OLYMPUS CF TYPE 2T160L | Withdrawn | |
| OLYMPUS CF TYPE 2T160I | Withdrawn | |
| OLYMPUS CF TYPE 2T160L | Withdrawn | |
| OLYMPUS CF TYPE 2T160L | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endocam | Richard Wolf Gmbh | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Karl Storz GmbH & Co. KG | 20 |
| Gimmi | Gimmi Gmbh | 9 |
| Image 1 | Karl Storz GmbH & Co. KG | 8 |
| Exalt™ | Boston Scientific Corporation | 8 |
| Conmed | ConMed Corporation | 7 |
| Video Adapter | Olympus Medical Systems Corp. | 6 |
| EleVision™ | Schölly Fiberoptic GmbH | 6 |
| Water Resistant CAP | Olympus Medical Systems Corp. | 5 |
| CystoView™ | Verathon Medical (Canada) ULC | 5 |
| Riwo | Richard Wolf Gmbh | 5 |
| Video Processor | Pentax of America, Inc. | 5 |
Showing 12 of 105. All products under Endoscopic Video Imaging System/Component, Gastroenterology-Urology
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K261260 | 2026-06-24 |
| K241371 | 2024-07-03 |
| K222584 | 2023-04-26 |
| K202646 | 2020-10-29 |
| K201200 | 2020-07-22 |
| K190449 | 2019-08-30 |
| K172817 | 2017-10-17 |
| K102059 | 2010-10-08 |
| K083155 | 2009-01-13 |
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 |
|---|---|---|---|---|---|---|
| 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 | 3344 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.