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FDA 510(k)

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)

K-Number: K243502 · 2025-01-17

ApplicantOlympus Medical Systems Corporation
Decision Date2025-01-17
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corporation. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K243502. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)?

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is Olympus Medical Systems Corporation. The 510(k) number is K243502.

When did EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) receive FDA 510(k) clearance?

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K243502.

Who is the listed applicant for EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)?

The FDA 510(k) record lists Olympus Medical Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3)?

The FDA product code for EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) is IYN.

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Other records listing Olympus Medical Systems Corporation as applicant

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K260856Disposable Distal Attachment D-201-13404K260401EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)K260824Gastrointestinal Videoscope Olympus GIF-2T1500K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K261260HD Camera Head OLYMPUS CH-S200-08-LBK252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

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Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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