Fusion OMNI Sphincterotome

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

Wilson-Cook Medical, Inc./ Cook Endoscopy

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc./ Cook Endoscopy with the FDA for Fusion Omni Sphincterotome.

Pre-market Notification Details

Device IDK172288
510k NumberK172288
Device Name:Fusion OMNI Sphincterotome
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant Wilson-Cook Medical, Inc./ Cook Endoscopy 4900 Bethania Station Road Winston Salem,  NC  27105
ContactSierra Lowe
CorrespondentSierra Lowe
Wilson-Cook Medical, Inc./ Cook Endoscopy 4900 Bethania Station Road Winston Salem,  NC  27105
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-31
Decision Date2018-04-17
Summary:summary

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