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FDA 510(k) Application Details - K220036
Device Classification Name
Catheter, Urological
More FDA Info for this Device
510(K) Number
K220036
Device Name
Catheter, Urological
Applicant
Well Lead Medical Co., Ltd.
No.47, Guomao Avenue South, Hualong, Panyu
Guangzhou 511434 CN
Other 510(k) Applications for this Company
Contact
Jenny Zhu
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
KOD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/05/2022
Decision Date
12/16/2022
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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