FDA 510(k)

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS

K-Number: K203128 · 2020-11-09

Decision Date2020-11-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2020-11-09 under 510(k) number K203128. 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-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS?

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS is a medical device that received FDA 510(k) clearance on 2020-11-09. The listed applicant is Olympus Medical Systems Corp.. The 510(k) number is K203128.

When did EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS receive FDA 510(k) clearance?

EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS received FDA 510(k) clearance on 2020-11-09, under 510(k) number K203128.

Who is the listed applicant for EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS?

The FDA 510(k) record lists Olympus Medical Systems Corp. 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-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS?

The FDA product code for EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS is IYN.

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Other records listing Olympus Medical Systems Corp. 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

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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.