Disposable Ureteral Access Sheath

Endoscopic Access Overtube, Gastroenterology-urology

Suzhou Beyo Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Suzhou Beyo Medical Technology Co., Ltd. with the FDA for Disposable Ureteral Access Sheath.

Pre-market Notification Details

Device IDK203165
510k NumberK203165
Device Name:Disposable Ureteral Access Sheath
ClassificationEndoscopic Access Overtube, Gastroenterology-urology
Applicant Suzhou Beyo Medical Technology Co., Ltd. No. 38 Beiguandu Road Suzhou,  CN 215000
ContactAline Qin
CorrespondentAline Qin
Suzhou Beyo Medical Technology Co., Ltd. No. 38 Beiguandu Road Suzhou,  CN 215000
Product CodeFED  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-23
Decision Date2021-04-30

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