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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 K182217
Device Name Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use
Applicant
Ezisurg (Suzhou) Medical Co., Ltd.
Building 16, No.8 Jinfeng Rd.
Suzhou National Hi-Tech District
Suzhou,  CN 215163
Applicant Contact Jingtian Ren
Correspondent
Mid-Link Consulting Co., Ltd
P.O.BOX 120-119
Shanghai,  CN 200120
Correspondent Contact Ying Xu
Regulation Number878.4750
Classification Product Code
GDW  
Subsequent Product Code
GAG  
Date Received08/15/2018
Decision Date 04/16/2019
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
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