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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K202467
Device Name Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads
Applicant
Fengh Medical Co., Ltd.
D3 No. 6 Dongsheng West Road,
Jiangyin National High-tech Zone
Jiangyin,  CN 214437
Applicant Contact Jiao Liu
Correspondent
Shanghai Medical Business Consulting Co., Ltd.
No. 170 Huajiang Road, Jiading District
Shanghai,  CN 201801
Correspondent Contact Julie Chen
Regulation Number878.4750
Classification Product Code
GDW  
Date Received08/27/2020
Decision Date 12/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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