Instinct Plus Endoscopic Clipping Device

Hemostatic Metal Clip For The Gi Tract

Cook Endoscopy

The following data is part of a premarket notification filed by Cook Endoscopy with the FDA for Instinct Plus Endoscopic Clipping Device.

Pre-market Notification Details

Device IDK192697
510k NumberK192697
Device Name:Instinct Plus Endoscopic Clipping Device
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Cook Endoscopy 4900 Bethania Station Road Winston-salem,  NC  27105
ContactKarthik Pillai
CorrespondentKarthik Pillai
Cook Endoscopy 4900 Bethania Station Road Winston-salem,  NC  27105
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
510k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-26
Decision Date2020-03-05

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