Single Use Hemoclip

Hemostatic Metal Clip For The Gi Tract

Zhejiang Chuangxiang Medical Technology Co., LTD.

The following data is part of a premarket notification filed by Zhejiang Chuangxiang Medical Technology Co., Ltd. with the FDA for Single Use Hemoclip.

Pre-market Notification Details

Device IDK212669
510k NumberK212669
Device Name:Single Use Hemoclip
ClassificationHemostatic Metal Clip For The Gi Tract
Applicant Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road, Yuhang District Hangzhou,  CN 311100
ContactLucius Long
CorrespondentLucius Long
Zhejiang Chuangxiang Medical Technology Co., LTD. 301B, No.22, XinYan Road, Yuhang District Hangzhou,  CN 311100
Product CodePKL  
CFR Regulation Number876.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-23
Decision Date2022-05-27

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