URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R

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 Uretero-reno Videoscope Olympus Urf-v3/v3r, Uretero-reno Fiberscope Olympus Urf-p7/p7r.

Pre-market Notification Details

Device IDK181451
510k NumberK181451
Device Name:URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
ClassificationUreteroscope And Accessories, Flexible/rigid
Applicant Olympus Medical Systems Corp. 2951 Ishikawa-cho Hachioji-shi,  JP 192-8507
ContactToshiyuki Nakajima
CorrespondentSheri L. Musgnung
Olympus Surgical Technologies America 3500 Corporate Parkway PO Box 610 Center Valley,  PA  18034 -0610
Product CodeFGB  
Subsequent Product CodeFBN
Subsequent Product CodeNWB
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-01
Decision Date2019-01-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04953170403835 K181451 000
04953170403811 K181451 000
04953170403392 K181451 000
04953170403385 K181451 000
04953170435133 K181451 000
04953170435119 K181451 000
04953170435102 K181451 000
04953170435096 K181451 000

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