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FDA 510(k) Application Details - K222421
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K222421
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No. 597 Kangxin Road Yuhang District
Hangzhou 311106 CN
Other 510(k) Applications for this Company
Contact
Jiayuan Zhang
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/11/2022
Decision Date
05/03/2023
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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