EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
FDA 510(k) K261183 · Olympus Medical Systems Corporation
510(k) numberK261183
Submission
- Device name
- EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- Applicant
- Olympus Medical Systems Corporation
Tokyo, JP - Received
- April 10, 2026
- Decision date
- July 31, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODG – Endoscopic Ultrasound System, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code ODG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260428 | RIVOS EUS Access Device (M00553900)ODG · Traditional | Boston Scientific Corporation | 06/17/2026SE |
| K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | Olympus Medical Systems Corporation | 10/03/2025SE |
| K251542 | InstaFANODG · Traditional | Onepass Medical , Ltd. | 07/18/2025SE |
| K231813 | Ultrasonic GastrovideoscopeODG · Traditional | Sonoscape Medical Corp. | 03/08/2024SE |
| K232518 | EndoSound Vision System; EVSODG · Traditional | Endosound, Inc. | 12/27/2023SE |
| K223616 | Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceODG · Special | Boston Scientific Corporation | 12/30/2022SE |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UTODG · Traditional | Fujifilm Corporation | 08/19/2022SE |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580URODG · Special | Fujifilm Corporation | 08/04/2022SE |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2ODG · Traditional | Fujifilm Corporation | 06/03/2022SE |
| K212852 | Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic…ODG · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 12/06/2021SE |
More from Micro-Tech (Nanjing) Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGE · Traditional | 03/06/2026SE |
Questions and answers
When was EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) cleared by the FDA?
EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K261183) received a 510(k) decision of Substantially Equivalent on July 31, 2026, 112 days after the submission was received.
What is the product code of K261183?
The FDA product code is ODG – Endoscopic Ultrasound System, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.