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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anoscope And Accessories
510(k) Number K230439
Device Name WellCare Anoscope
Applicant
Well Care (Wuhan) Medical Technology Co., Ltd
No. 11# The No.1 Road Fozuling of East Lake High-Tech
Development Zone
Wuhan,  CN 430205
Applicant Contact Zhou Huimin
Correspondent
Well Care (Wuhan) Medical Technology Co., Ltd
No. 11# The No.1 Road Fozuling of East Lake High-Tech
Development Zone
Wuhan,  CN 430205
Correspondent Contact Zhou Huimin
Regulation Number876.1500
Classification Product Code
FER  
Date Received02/21/2023
Decision Date 12/22/2023
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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