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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 K171825
Device Name Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument
Applicant
Hunan Handlike Minimally Invasive Surgery Co., Ltd.
A4, Lugu Yuyuan, #27, Wenxuan Rd.
High-Tech Zone
Changsha,  CN
Applicant Contact Hu hanhan
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Rm. 1122, # 55 Shizhou Middle Rd.,
Nanshan District
Shenzhen,  CN GD755
Correspondent Contact Elly Xu
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/19/2017
Decision Date 02/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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