Instrument Tray, For Semi-rigid Ureteroscope

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Olympus Winter & Ibe GmbH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Instrument Tray, For Semi-rigid Ureteroscope.

Pre-market Notification Details

Device IDK203492
510k NumberK203492
Device Name:Instrument Tray, For Semi-rigid Ureteroscope
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant Olympus Winter & Ibe GmbH Kuehnstr, 61 Hamburg,  DE 22045
ContactJan-oliver Upmeier
CorrespondentDolan Mills
Olympus Surgical Technologies America 118 Turnpike Road Southborough,  MA  01772
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-19
Decision Date2021-09-15

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