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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Ablation, Microwave And Accessories
510(k) Number K252632
Device Name Microwave Ablation Device
Applicant
Nanjing Dewen Medical Technology Co., Ltd.
Bldg. 9, 3rd Floor, # 86, Shuanggao Rd., Economic Developmen
Nanjing,  CN 211300
Applicant Contact Qiuling Liu
Correspondent
APlus Healthcare Technology (Shanghai) Co., Ltd.
1201 Floor, Zhongzhi Bldg., #9299 Humin Rd., Xuhui District
Shanghai,  CN
Correspondent Contact Jack Fang
Regulation Number878.4400
Classification Product Code
NEY  
Date Received08/20/2025
Decision Date 03/02/2026
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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