Single Use Ureteral Access Sheath

Endoscopic Access Overtube, Gastroenterology-urology

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 Ureteral Access Sheath.

Pre-market Notification Details

Device IDK220065
510k NumberK220065
Device Name:Single Use Ureteral Access Sheath
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant Zhejiang Chuangxiang Medical Technology Co., Ltd. Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou,  CN 311100
ContactLucius Long
CorrespondentLucius Long
Zhejiang Chuangxiang Medical Technology Co., Ltd. Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District Hangzhou,  CN 311100
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-10
Decision Date2022-05-25

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