EndoClot

Hemostatic Device For Endoscopic Gastrointestinal Use

EndoClot Plus Co., Ltd.

The following data is part of a premarket notification filed by Endoclot Plus Co., Ltd. with the FDA for Endoclot.

Pre-market Notification Details

Device IDK190677
510k NumberK190677
Device Name:EndoClot
ClassificationHemostatic Device For Endoscopic Gastrointestinal Use
Applicant EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street Suzhou Industrial Park Suzhou,  CN 215000
ContactHuihui Xie
CorrespondentJonathan Hu
Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai,  CN 200093
Product CodeQAU  
CFR Regulation Number878.4456 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-15
Decision Date2021-01-29

Trademark Results [EndoClot]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOCLOT
ENDOCLOT
85322084 4412920 Live/Registered
EndoClot Plus, Inc.
2011-05-16

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