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FDA 510(k) Application Details - K190032
Device Classification Name
Endoscopic Injection Needle, Gastroenterology-Urology
More FDA Info for this Device
510(K) Number
K190032
Device Name
Endoscopic Injection Needle, Gastroenterology-Urology
Applicant
Hangzhou AGS MedTech CO., Ltd
Building 5, Building 6, Kangxin Road No.597
Yuhang District
Hangzhou 310000 CN
Other 510(k) Applications for this Company
Contact
Xiangyong Yu
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
FBK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/2019
Decision Date
02/27/2020
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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