Evis Exera III Duodenovideoscope Olympus TJF-Q190V

Duodenoscope And Accessories, Flexible/rigid

Olympus Medical Systems Corp.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Evis Exera Iii Duodenovideoscope Olympus Tjf-q190v.

Pre-market Notification Details

Device IDK193182
510k NumberK193182
Device Name:Evis Exera III Duodenovideoscope Olympus TJF-Q190V
ClassificationDuodenoscope And Accessories, Flexible/rigid
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L. Musgnung
Olympus Corporation Of The Americas 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeFDT  
Subsequent Product CodeNWB
Subsequent Product CodeOCX
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-18
Decision Date2020-01-17


Device IdentifiersubmissionNumberSupplement
04953170405600 K193182 000
04953170405563 K193182 000
14953170403016 K193182 000

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