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

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06936534303956 K220065 000
06936534304120 K220065 000
06936534304113 K220065 000
06936534304106 K220065 000
06936534304090 K220065 000
06936534304083 K220065 000
06936534304076 K220065 000
06936534304069 K220065 000
06936534304052 K220065 000
06936534304045 K220065 000
06936534304038 K220065 000
06936534304021 K220065 000
06936534304014 K220065 000
06936534304007 K220065 000
06936534303994 K220065 000
06936534303987 K220065 000
06936534304137 K220065 000
06936534304144 K220065 000
06936534304151 K220065 000
06936534303949 K220065 000
06936534303932 K220065 000
06936534303925 K220065 000
06936534303918 K220065 000
06936534304267 K220065 000
06936534304250 K220065 000
06936534304243 K220065 000
06936534304236 K220065 000
06936534304229 K220065 000
06936534304212 K220065 000
06936534304205 K220065 000
06936534304199 K220065 000
06936534304182 K220065 000
06936534304175 K220065 000
06936534304168 K220065 000
06936534303970 K220065 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.