Visera Hysterovideoscope Olympus HYF Type V

Hysteroscope (and Accessories)

Olympus Medical Systems Corporation

The following data is part of a premarket notification filed by Olympus Medical Systems Corporation with the FDA for Visera Hysterovideoscope Olympus Hyf Type V.

Pre-market Notification Details

Device IDK221557
510k NumberK221557
Device Name:Visera Hysterovideoscope Olympus HYF Type V
ClassificationHysteroscope (and Accessories)
Applicant Olympus Medical Systems Corporation 2951 Ishikawa-cho, Hachioji-shi Tokyo,  JP
ContactToshio Nakamura
CorrespondentGary Brennan
Olympus Corporation Of The Americas 800 West Park Drive Westborough,  MA  01581
Product CodeHIH  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-31
Decision Date2022-09-02

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