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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K254231
Device Name Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating Clips
Applicant
Taiwan Surgical Corporation
3f., # 12, Sec. 12, Sheng Yi Rd., Hsinchu County
Zhubei City,  TW 30261
Applicant Contact Ken Chen
Correspondent
Taiwan Surgical Corporation
3f., # 12, Sec. 12, Sheng Yi Rd., Hsinchu County
Zhubei City,  TW 30261
Correspondent Contact Ken Chen
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received12/29/2025
Decision Date 07/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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