OES Elite Ureteroscopes And Accessories

Ureteroscope And Accessories, Flexible/rigid

Olympus Winter & Ibe GmbH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Oes Elite Ureteroscopes And Accessories.

Pre-market Notification Details

Device IDK200369
510k NumberK200369
Device Name:OES Elite Ureteroscopes And Accessories
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg,  DE 22045
ContactStefanie Weber
CorrespondentChristina Flores
Olympus Surgical Technologies America 118 Turnpike Road Southborough,  MA  01772 -2104
Product CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-14
Decision Date2020-08-28

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