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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 K250551
Device Name 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N)
Applicant
Shenzhen Sophway Technology Co., Ltd.
A1301a, Bldg. 1, Meixun Digital Technology Factory, #19
Jinxiu Middle Rd., Laokeng Community, Longtian St., Ping Dis
Shenzhen,  CN
Applicant Contact Shuting Chen
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/25/2025
Decision Date 10/02/2025
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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