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510(k) K251859

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) by Olympus Medical Systems Corporation — Product Code ODG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2025
Date Received
June 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Ultrasound System, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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).

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  • K203166 — PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultraso (December 30, 2020)
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