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.

Related Clinical Trials

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.

NCT02872831Beacon BNX™ Endoscopic Ultrasound (EUS)-Needle vs SharkCore™ NeedleWITHDRAWN NCT06174805AXIOS™ Gastroenterostomy for Gastric Outlet Obstruction IDESUSPENDED NCT07136324Safety and Efficacy of EUS-RFA in the Treatment of Pancreatic Lesions: A Prospective RegistryACTIVE_NOT_RECRUITING NCT07737171Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic LesionsRECRUITING NCT03444948A Clinical Study of EUS-RFA for Inoperable Pancreatic Ductal AdenocarcinomaSUSPENDED NCT04990609EUS-RFA PANCARDINAL-1 TrialRECRUITING

Other records listing Olympus Medical Systems Corporation as applicant

K261183EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)K261260HD Camera Head OLYMPUS CH-S200-08-LB K260580Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090, HX-610-135); Long Clip (HX-610-090L, HX-610-135L); Short Clip (HX-610-090S, HX-610-135S); Super Short Clip (HX-610-135XS)K252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D

View all 112 devices →

Related Devices (Code: IYN)

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.