SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

OLYMPUS MEDICAL SYSTEMS COPR.

The following data is part of a premarket notification filed by Olympus Medical Systems Copr. with the FDA for Single Use Preloaded Sphincterotome V (distal Wireguided); Single Use Sp.

Pre-market Notification Details

Device IDK141991
510k NumberK141991
Device Name:SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED); SINGLE USE SP
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant OLYMPUS MEDICAL SYSTEMS COPR. 3500 CORPORATE PARKWAY PO BOX 610 Center Valley,  PA  18034 -0610
ContactDaphney Germain-kolawole
CorrespondentDaphney Germain-kolawole
OLYMPUS MEDICAL SYSTEMS COPR. 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 Received2014-07-22
Decision Date2015-03-31
Summary:summary

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