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FDA 510(k) Application Details - K222261
Device Classification Name
Choledochoscope And Accessories, Flexible/Rigid
More FDA Info for this Device
510(K) Number
K222261
Device Name
Choledochoscope And Accessories, Flexible/Rigid
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd
3 Floor, Building No.1, 4299 JinDu Road, Minhang District
Shanghai 201108 CN
Other 510(k) Applications for this Company
Contact
Yihua Ma
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FBN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/28/2022
Decision Date
04/20/2023
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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