Evis Exera II Colonovideoscope
"PCF-H180AI Evis Exera II Ultra Thin Clnv"
9manufacturers in China registered for this device type
8catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Shanghai (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| 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 |
| Sumitomo Bakelite (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 3 |
| Daichuan Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FDS |
| Device type | Gastroscope And Accessories, Flexible/Rigid |
| 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| OLYMPUS CF TYPE H180AL | Withdrawn | |
| OLYMPUS CF TYPE H180DI | Withdrawn | |
| OLYMPUS CF TYPE H180AL | Withdrawn | |
| OLYMPUS CF TYPE H180DL | Withdrawn | |
| OLYMPUS PCF TYPE H180AI | Withdrawn | |
| OLYMPUS PCF TYPE H180AI | Withdrawn | |
| OLYMPUS PCF TYPE Q180AL | Withdrawn | |
| OLYMPUS CF TYPE H180AL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pentax | Hoya Corporation | 72 |
| Fujifilm | Fujifilm Corporation | 43 |
| Disposable Distal Attachment | Olympus Medical Systems Corp. | 27 |
| Disposable Distal Cap | Micro-Tech (Nanjing) Co., Ltd. | 26 |
| Video Gastroscope | Pentax of America, Inc. | 20 |
| Gyrus Acmi | Gyrus Acmi, Inc. | 18 |
| Medisono | Medisono, LLC | 18 |
| Gastroscope And Accessories, Flexible/Rigid | Karl Storz GmbH & Co. KG | 17 |
| Distal Attachment | Olympus Medical Systems Corp. | 14 |
| Disposable EMR KIT | Olympus Medical Systems Corp. | 12 |
| Fuse® | Endochoice, Inc. | 11 |
| Evis Exera II Gastrointestinal Videoscope | Olympus Medical Systems Corp. | 9 |
Showing 12 of 66. All products under Gastroscope And Accessories, Flexible/Rigid
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260824 | 2026-08-27 |
| K260856 | 2026-08-27 |
| K250296 | 2025-05-01 |
| K232997 | 2024-06-19 |
| K123317 | 2012-12-11 |
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 | 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.