Single Use Retrieval Nitinol Basket V

Dislodger, Stone, Biliary

OLYMPUS MEDICAL SYSTEMS CORP.

The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Retrieval Nitinol Basket V.

Pre-market Notification Details

Device IDK170811
510k NumberK170811
Device Name:Single Use Retrieval Nitinol Basket V
ClassificationDislodger, Stone, Biliary
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 Ishikawa-cho Hachioji,  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 CodeLQR  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-17
Decision Date2017-11-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170395328 K170811 000

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