Instinct Plus Endoscopic Clipping Device

Hemostatic Metal Clip For The Gi Tract

Wilson-Cook Medical Inc.

The following data is part of a premarket notification filed by Wilson-cook Medical Inc. with the FDA for Instinct Plus Endoscopic Clipping Device.

Pre-market Notification Details

Device IDK212323
510k NumberK212323
Device Name:Instinct Plus Endoscopic Clipping Device
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
ContactScottie Fariole
CorrespondentScottie Fariole
Wilson-Cook Medical Inc. 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-26
Decision Date2021-08-25

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