Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)

K-Number: K251859 · 2025-10-03

ApplicantOlympus Medical Systems Corporation
Decision Date2025-10-03
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is a medical device manufactured by Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-10-03 under approval number K251859. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is a medical device that received FDA 510(k) clearance on 2025-10-03. It is manufactured by Olympus Medical Systems Corporation. The 510(k) number is K251859.

When was EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) approved by the FDA?

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) received FDA 510(k) clearance on 2025-10-03, under approval number K251859.

What company makes EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is manufactured by Olympus Medical Systems Corporation.

What is the FDA product code for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)?

The FDA product code for EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) is ODG.

Related Clinical Trials

NCT07548281 Intravascular Ultrasound- and Angiography-Derived Fractional Flow Reserve-Guided Drug-Coated Balloon for Large Coronary Artery De Novo Lesions NOT_YET_RECRUITING NCT02052063 Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ? COMPLETED NCT02872831 Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ Needle WITHDRAWN

Other Devices by Olympus Medical Systems Corporation

K211838Ultrasonic Bipolar Generator USG-410 with accessories K221557Visera Hysterovideoscope Olympus HYF Type V K222861EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222584EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K221683CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K242357Water Container (MAJ-901); Water Container (MAJ-902)

View all 31 devices →

Related Devices (Code: ODG)

K160845Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) DeviceBoston Scientific Corporation K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K172309Endoscopic Ultrasound Aspiration NeedleMicro-Tech (Nanjing) Co., Ltd. K162447PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound ScannerPentax of America, Inc. K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration NeedleBoston Scientific K182004PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑