EndoClot

Submucosal Injection Agent

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 IDK191254
510k NumberK191254
Device Name:EndoClot
ClassificationSubmucosal Injection Agent
Applicant EndoClot Plus Co., Ltd. 101 Room, B8 Building, 218 Xinghu Street, Suzhou Industrial Park Suzhou,  CN 215000
ContactHendry Zhang
CorrespondentJonathan Hu
Medwheat (Shanghai) Medical Technology Co., Ltd. Yangpu District Liaoyuan East Road Shuangyang First Suite No. 33 Room 303 Shanghai,  CN 200093
Product CodePLL  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-10
Decision Date2020-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
26972011720216 K191254 000
26972011720254 K191254 000
26972011720247 K191254 000

Trademark Results [EndoClot]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOCLOT
ENDOCLOT
97292080 not registered Live/Pending
EndoClot Plus, Inc.
2022-03-02
ENDOCLOT
ENDOCLOT
85322084 4412920 Live/Registered
EndoClot Plus, Inc.
2011-05-16

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