Sheath, Stopcock Accessory

Hysteroscope (and Accessories)

Olympus Winter & Ibe GmbH

The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Sheath, Stopcock Accessory.

Pre-market Notification Details

Device IDK213207
510k NumberK213207
Device Name:Sheath, Stopcock Accessory
ClassificationHysteroscope (and Accessories)
Applicant Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg,  DE 22045
ContactKatharina Campbell
CorrespondentJonathan Gilbert
Olympus Corporation Of The Americas (OCA) 3500 Corporate Parkway Center Valley,  PA  18034
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-29
Decision Date2021-12-22

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