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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K250130
Device Name Viction Disposable Irrigation and suction System (VC-FLA0514; VC-FLA0523; VC-FLA0532; VC-FLB0514; VC-FLB0523; VC-FLB0532; VC-FLC0514; VC-FLC0523; VC-FLC0532; VC-FLD0514; VC-FLD0523; VC-FLD0532)
Applicant
Hangzhou Viction Medical Technology Co.,Ltd
First Floor ,#1 Bldg., #95 Binwen Rd.,
Binjiang District
Hangzhou,  CN 310051
Applicant Contact Zhicong Luo
Correspondent
Hangzhou Viction Medical Technology Co.,Ltd
First Floor ,#1 Bldg., #95 Binwen Rd.,
Binjiang District
Hangzhou,  CN 310051
Correspondent Contact Zhicong Luo
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/17/2025
Decision Date 08/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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