Evis Exera III Gastrointestinal Videoscope
The Olympus GIF-1TH190 is an upper gastrointestinal videoscope for endoscopy and endoscopic surgery in the esophagus, stomach and duodenum. It works with an Olympus video system center,…
The Olympus GIF-1TH190 is an upper gastrointestinal videoscope for endoscopy and endoscopic surgery in the esophagus, stomach and duodenum. It works with an Olympus video system center, light source, monitor and compatible endotherapy instruments.
Control knobs bend the distal section up, down, left and right to guide insertion and observation. The flexible insertion section carries the viewing and light paths and provides an instrument channel for biopsy tools and other accessories.
Listed Item
GIF-1TH190 GIF-1TH190 Evis Exera III HIG
Suction and Lens Washing
A suction valve removes fluid that obscures the view. An air and water valve supplies lens washing water or air to clear debris from the objective lens. The scope’s connector links it to the external video and illumination equipment.
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 |
| 510(k) | K232997 |
| Record published | 2016-09-21 |
| Record revised | 2024-06-27 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS GIF-1TH190 | In distribution | |
| OLYMPUS GIF-1TH190 | In distribution | |
| OLYMPUS GIF-1TH190 | In distribution |
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
3 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 | 510(k) number | 2024-10-31 | Class II | Under Investigation by firm | High-level disinfection (“HLD”) with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor (“AER”) has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 E | 1,770 units |
| Olympus Corporation of the Americas | 510(k) number | 2024-09-18 | Class II | Reprocessing Controls | To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH19 | 1749 units |
| Olympus Corporation of the Americas | UDI-DI | 2023-10-02 | Class II | Reprocessing Controls | Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. | 1687 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.