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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K260197
Device Name Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B)
Applicant
Suzhou Shenyun Medical Equipment Co., Ltd.
Bldg. 11, # 666, Yinzang Rd.
Linhu Town, Wuzhong District
Suzhou,  CN 215105
Applicant Contact Yuan Liu
Correspondent
Zhihe Info-Tech(Suzhou) Co., Ltd.
Bldg. 1, # 1 Huayun Rd., Industrial Park
Suzhou,  CN 215000
Correspondent Contact Rachel Yu
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received01/22/2026
Decision Date 04/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
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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