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FDA 510(k) Application Details - K230200
Device Classification Name
Ureteroscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K230200
Device Name
Ureteroscope And Accessories, Flexible/Rigid
Applicant
Hunan Vathin Medical Instrument Co., Ltd.
1/F, Building 12, Innovation Entrepreneurship Service Center
No.9 Chuanqi West Rd, Jiuhua Economic Development Zone
Xiangtan 411100 CN
Other 510(k) Applications for this Company
Contact
Du Jing
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FGB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/25/2023
Decision Date
05/18/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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