Hemospray Endoscopic Hemostat

Hemostatic Device For Endoscopic Gastrointestinal Use

Wilson-Cook Medical, Inc

The following data is part of a De Novo classification by Wilson-cook Medical, Inc with the FDA for Hemospray Endoscopic Hemostat.

Pre-market Notification Details

DeNovo IDDEN170015
Device Name:Hemospray Endoscopic Hemostat
ClassificationHemostatic Device For Endoscopic Gastrointestinal Use
Applicant Wilson-Cook Medical, Inc 4900 Bethania Station Road Winston-salem,  NC  27105
ContactMarge Walls-walker
Product CodeQAU  
CFR Regulation Number878.4456 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2017-03-09
Decision Date2018-05-07
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00827002565722 DEN170015 000
00827002210493 DEN170015 000

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