Single Use Balloon Dilator V (with Knife)

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

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 Balloon Dilator V (with Knife).

Pre-market Notification Details

Device IDK150142
510k NumberK150142
Device Name:Single Use Balloon Dilator V (with Knife)
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji-shi,  JP 192-8507
ContactToshiyuji Nakajima
CorrespondentDaphney Germain-kolawole
OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-01-22
Decision Date2015-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14953170373999 K150142 000
14953170373975 K150142 000
14953170373951 K150142 000

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