EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
FDA 510(k) clearance K251859 · decided 2025-10-03
Clearance details
- K-number
- K251859
- Device name
- EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
- Applicant
- Olympus Medical Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2025-06-17
- Decision date
- 2025-10-03
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- ODG
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tokyo, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) (K261183) | Olympus Medical Systems Corporation | 2026-07-31 |
| RIVOS™ EUS Access Device (M00553900) (K260428) | Boston Scientific Corporation | 2026-06-17 |
| InstaFAN (K251542) | Onepass Medical , Ltd. | 2025-07-18 |
| Ultrasonic Gastrovideoscope (K231813) | Sonoscape Medical Corp. | 2024-03-08 |
| EndoSound Vision System; EVS (K232518) | Endosound, Inc. | 2023-12-27 |
| Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K223616) | Boston Scientific Corporation | 2022-12-30 |
| FUJIFILM Ultrasonic Endoscope EG-740UT (K221238) | Fujifilm Corporation | 2022-08-19 |
| Endoscope Model EG-580UT and Endoscope Model EG-580UR (K221952) | Fujifilm Corporation | 2022-08-04 |
| FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (K214089) | Fujifilm Corporation | 2022-06-03 |
| Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle (K212852) | Micro-Tech (Nanjing) Co., Ltd. | 2021-12-06 |
| PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K203166) | Pentax of America, Inc. | 2020-12-30 |
| PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) (K200090) | Pentax of America, Inc. | 2020-07-23 |
Recalls involving this device
No recalls on record reference this clearance.