Name: Predicase
Price: 199 USD

K-number	K251859
Device name	EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Applicant	Olympus Medical Systems Corporation
Product code	ODG
Device class	Class II
Decision date	Oct 3, 2025
Decision	Substantially Equivalent
Regulation	876.1500

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

Everything you need for a 510(k) submission. Nothing you don't.