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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 K260414
Device Name “Tech-Image” Video Endoscope System
Applicant
Tech-Image CO., LTD.
11 F., # 37, Sec. 3, Minquan E. Rd.,
Zhongshan Dist.
Taipei City,  TW 104478
Applicant Contact Hsin-Tzu Lu
Correspondent
WeMED Bio-Tech, Inc.
12f.-6, #99, Sec. 1, Xintai 5th Rd., Xizhi Dist.
New Taipei City,  TW 221416
Correspondent Contact Yin-Jiun Tseng
Regulation Number876.1500
Classification Product Code
GCJ  
Subsequent Product Code
HRX  
Date Received02/09/2026
Decision Date 06/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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