Evis Exera III Colonovideoscope
4 catalogue numbers from OLYMPUS PCF-H190TL, listed by Olympus Medical Systems Corp., Japan, under Colonoscope And Accessories, Flexible/Rigid. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
4catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dalian Create Medical Products Co., Ltd. | Dalian | Liaoning | Contract manufacturer | 2 |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Alton Shanghai Medical Instruments Co Ltd | Shanghai | Shanghai | Complaint-file establishment | 20 |
| Hangzhou AGS MedTech Co., Ltd. | Hangzhou | Zhejiang | Repacker / relabeller | 19 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Sonoscape Medical Corp. | Shenzhen | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FDF |
| Device type | Colonoscope And Accessories, Flexible/Rigid |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K192793 |
| Record published | 2016-09-21 |
| Record revised | 2024-01-15 (version 7) |
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 | 2024-01-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS PCF-H190TL | In distribution | |
| OLYMPUS PCF-HQ190I | In distribution | |
| OLYMPUS PCF-H190DL | Withdrawn | |
| OLYMPUS PCF-H190DI | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fuse | Endochoice, Inc. | 52 |
| Colonoscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 51 |
| Fujifilm | Fujifilm Corporation | 40 |
| Pentax | Hoya Corporation | 37 |
| Video Colonoscope | Pentax of America, Inc. | 25 |
| G-EYE Colonoscope | Smart Medical Systems Ltd. | 24 |
| Medisono | Medisono, LLC | 18 |
| Evis Exera lll Colonovideoscope | Olympus Medical Systems Corp. | 16 |
| Endoch | Endoch Inc | 14 |
| Evis Exera II Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonovideoscope | Olympus Medical Systems Corp. | 12 |
| Colonoscope And Accessories, Flexible/Rigid | Hangzhou AGS MedTech Co., Ltd. | 10 |
Showing 12 of 115. All products under Colonoscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250432 | 2025-05-15 |
| K192793 | 2020-07-17 |
| K131780 | 2013-08-29 |
| K111756 | 2012-03-20 |
| K112680 | 2012-02-16 |
| K103312 | 2011-05-12 |
| K101053 | 2010-07-14 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| 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. | 47 |
| Olympus Corporation of the Americas | 510(k) number | 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. | 1 |
| Olympus Corporation of the Americas | 510(k) number | 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. | 28 |
| Aizu Olympus Co., Ltd. | UDI-DI | 2023-10-16 | Class II | Process control | Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to e | 24 incorrectly repaired units |
| Aizu Olympus Co., Ltd. | 510(k) number | 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 |
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.