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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K220722
Device Name PVC Hydrophilic Urethral Catheter
Applicant
Well Lead Medical Co., Ltd.
No. 47 Guomao Avenue South, Hualong, Panyu
Guangzhou,  CN 511434
Applicant Contact Jenny Zhu
Correspondent
Well Lead Medical Co., Ltd.
No. 47 Guomao Avenue South, Hualong, Panyu
Guangzhou,  CN 511434
Correspondent Contact Jenny Zhu
Regulation Number876.5130
Classification Product Code
EZD  
Date Received03/14/2022
Decision Date 05/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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