Evis Exera Lll Gastrointestinal Videoscope
The Olympus GIF-XP190N is a gastrointestinal videoscope for endoscopy and endoscopic surgery in the upper digestive tract. It can be introduced through the mouth or nose to examine the…
The Olympus GIF-XP190N is a gastrointestinal videoscope for endoscopy and endoscopic surgery in the upper digestive tract. It can be introduced through the mouth or nose to examine the esophagus, stomach and duodenum. It operates as a component of the EVIS EXERA III video system.
The scope is used with an Olympus video system center, light source, monitor and documentation equipment. EndoTherapy accessories, such as biopsy forceps, can be used with the scope as part of the procedure. Its connector integrates the light-guide and electronic video contacts.
Listed Item
GIF-XP190N Ultra-Slim Scope, 4-WAY, NBI
Instrument Features
The described configuration includes a revised nozzle and compatibility with high-frequency electrocautery. These features belong to the GIF-XP190N scope and its associated equipment configuration. The videoscope is intended for upper gastrointestinal access rather than a general-purpose scope for every body cavity.
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) | K123317 |
| Record published | 2016-09-21 |
| Record revised | 2024-04-22 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLYMPUS GIF-XP190N | In distribution | |
| OLYMPUS GIF-XP190N | 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 |
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.