What is FDA product code ODG?

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Gastroenterology & Urology › DiagnosticEndoscopic Ultrasound System, Gastroenterology-Urology

Evis EUS Ultrasound Gastrointestinal Videoscope

Name: Evis EUS Ultrasound Gastrointestinal Videoscope
Brand: Evis EUS Ultrasound Gastrointestinal Videoscope

The Olympus GF-UE190 combines endoscopic viewing with real-time ultrasound imaging of the upper gastrointestinal tract and surrounding organs. It is used by appropriately trained healthcare…

Registry build 21.09.26

The Olympus GF-UE190 combines endoscopic viewing with real-time ultrasound imaging of the upper gastrointestinal tract and surrounding organs. It is used by appropriately trained healthcare professionals in healthcare facilities with compatible ultrasound, video and light-source equipment.

Its electronic radial ultrasound array scans through 360 degrees around the insertion direction. The optical channel provides a forward-oblique endoscopic view, while a separate instrument channel allows use of compatible endoscopic accessories during the examination.

Scope Configuration

The scope has a 1250 mm working length and a 2.2 mm instrument channel. Its tip can be angled up, down, left and right. Ultrasound contact is achieved using a balloon or sterile deaerated water, according to the system configuration.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Jiangsu.

Chinese manufacturers registered for FDA product code ODG
Manufacturer	City	Province	Registered as	Device types
Micro-Tech (Nanjing) Co., Ltd.	Nan Jing	Jiangsu	Contract manufacturer	49

Record

Regulatory record for Evis EUS Ultrasound Gastrointestinal Videoscope
Listed by	Olympus Medical Systems Corp., Japan
FDA product code	ODG
Device type	Endoscopic Ultrasound System, Gastroenterology-Urology
Device class	Class 2
Regulation	21 CFR 876.1500
Establishment	Specification developer, Manufacturer, Exporter
510(k)	K251859
Record published	2025-11-19

Specifications

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
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Evis EUS Ultrasound Gastrointestinal Videoscope
Catalogue number	Size	Status
OLYMPUS GF-UE190		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Pentax	Hoya Corporation	22
Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)	Micro-Tech (Nanjing) Co., Ltd.	12
Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)	Micro-Tech (Nanjing) Co., Ltd.	6
Pentax Medical	Hoya Corporation	6
Water-resistant Cap	Olympus Medical Systems Corp.	6
Expect	Boston Scientific Corporation	4
Ultrasonic Probe	Olympus Medical Systems Corp.	4
BALLOON3	Olympus Medical Systems Corp.	3
Acquire	Boston Scientific Corporation	3
Evis-EUS Image Cable	Olympus Medical Systems Corp.	3
Expect Slimline SL	Boston Scientific Corporation	3
Evis Exera II Ultrasound Gastrovideoscope	Olympus Medical Systems Corp.	2

Showing 12 of 52. All products under Endoscopic Ultrasound System, Gastroenterology-Urology

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K261183	2026-07-31
K251859	2025-10-03

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.