OLYMPUS URF-V2/V2R

Ureteroscope 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 Olympus Urf-v2/v2r.

Pre-market Notification Details

Device IDK172246
510k NumberK172246
Device Name:OLYMPUS URF-V2/V2R
ClassificationUreteroscope 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 CodeFGB  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-26
Decision Date2018-03-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170343612 K172246 000
04953170343582 K172246 000

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