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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Retention Type, Balloon
510(k) Number K243011
Device Name Silicone Urethral Catheter (Silicone Urethral Catheter)
Applicant
Guangdong Ecan Medical Co., Ltd.
Bldg. 1, # 222, Xindu Rd., Chengjiao St.,
Conghua District
Guangzhou,  CN 510920
Applicant Contact Liuyuan Han
Correspondent
Guangdong Ecan Medical Co., Ltd.
Bldg. 1, # 222, Xindu Rd., Chengjiao St.,
Conghua District
Guangzhou,  CN 510920
Correspondent Contact Summer Wang
Regulation Number876.5130
Classification Product Code
EZL  
Subsequent Product Code
EZD  
Date Received09/26/2024
Decision Date 06/16/2025
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
Predetermined Change
Control Plan Authorized		 No
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