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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K260466
Device Name Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)
Applicant
Zhejiang shuyou Surgical Instrument Co., Ltd.
3689#, E. Yangguang Ave., Dipu St. Anji
Huzhou,  CN 313300
Applicant Contact Jialong Wu
Correspondent
Zhejiang shuyou Surgical Instrument Co., Ltd.
3689#, E. Yangguang Ave., Dipu St. Anji
Huzhou,  CN 313300
Correspondent Contact Jialong Wu
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/12/2026
Decision Date 04/07/2026
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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