AcuSnare Polypectomy Snare - Duckbill

Snare, Flexible

Wilson-Cook Medical, Inc.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Acusnare Polypectomy Snare - Duckbill.

Pre-market Notification Details

Device IDK191048
510k NumberK191048
Device Name:AcuSnare Polypectomy Snare - Duckbill
ClassificationSnare, Flexible
Applicant Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
ContactDoris A. Hawks
CorrespondentDoris A. Hawks
Wilson-Cook Medical, Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodeFDI  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-19
Decision Date2019-07-18

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