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 Exera II Ultrasound Gastrovideoscope

Name: Evis Exera II Ultrasound Gastrovideoscope
Brand: Evis Exera II Ultrasound Gastrovideoscope

2 catalogue numbers from OLYMPUS GF TYPE UCT180, listed by Olympus Medical Systems Corp., Japan, under Endoscopic Ultrasound System, Gastroenterology-Urology. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

2catalogue numbers in this listing

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 Exera II Ultrasound Gastrovideoscope
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
Record published	2017-10-06
Record revised	2025-11-24 (version 9)

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
Distribution end date	2022-08-12
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Evis Exera II Ultrasound Gastrovideoscope
Catalogue number	Size	Status
OLYMPUS GF TYPE UCT180		In distribution
OLYMPUS GF TYPE UCT180		Withdrawn

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
Keyboard	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.